Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Purjes Foundation | UNKNOWN |
| The Greenbaum Foundation | UNKNOWN |
| Nitric Oxide Innovations LLC | INDUSTRY |
| National Institutes of Health (NIH) |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.
Visit 1:
After reviewing and signing consent, subjects will be screened for the study. Screening will consist of the following:
If the IIEF score is abnormal, subjects will be advised to contact their primary care provider.
Each subject will be contacted by phone with their blood results. If abnormal subject will be given the recommendation to contact his primary care provider.
If an abnormal finding is identified during screening, such as an abnormal STOP-bang score, subject will be given the recommendation to contact his primary care provider.
If the subject has no primary care provider, contact information for primary care will be given.
Subjects meeting inclusion and exclusion criteria will be randomized into the study, into either Sequence One or Sequence Two. Once enrolled, subjects will be asked to not modify their dietary habits throughout the duration of the study other than during the two evenings and two full days when food is provided (see below).
Sequence One:
Visit 2:
Subjects will return to the study center in the morning after having fasted (other than consuming water) since 11pm the night before. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be made. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
Subjects will be taught how to use the Rigiscan™ device. Subjects will receive one plant-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and they will consume their usual diet until 5pm. For the rest of the evening until 11pm they will consume only the dinner provided. Water will be the only beverage allowed after 5pm. Dinner should be consumed at 8:30pm EST. Subjects will text pictures of everything they consume (eat or drink) after 5pm to Dr. Ostfeld or to a study representative and s/he will have text or verbal contact with the subject at least once that evening. That night, subjects will do a Rigiscan™ assessment overnight at their home. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours.
Visit 3 Subjects will return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device with them. They will have been fasting other than drinking water since 11pm the night before. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be taken. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
Subjects will then receive one full day of plant-based meals (food will be provided by Montefiore-Einstein Food Services.) Subjects will be encouraged to eat breakfast at the study center after the initial anthropomorphic measures are made, saliva is obtained, and blood is drawn. Subjects will text pictures of all they consume during that day to Dr. Ostfeld and/or to a study representative and s/he will have text or verbal contact with the subject at least twice during that day. Dinner should be consumed at 8:30pm, EST. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. Black coffee and/or tea is permitted only before noon. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours.
Visit 4 Subjects will return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device with them. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be taken. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
There will then be a washout period for 8-12 days and subjects will be instructed to return to their usual dietary habits during this washout period. Number of days of the washout period will be recorded.
Visit 5 After the washout period, subjects will return to the study center in the morning after having fasted (other than consuming water) since 11pm the night before. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be taken. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
Subjects will receive one animal-based dinner (food will be provided by Montefiore-Einstein Food Services.) Subjects will then leave the study center and they will consume their usual diet until 5pm. For the rest of the evening until 11pm they will consume only the dinner provided. Water will be the only beverage consumed after 5pm. Dinner should be consumed at 8:30pm, EST. Subjects will text pictures of all they consume (eat or drink) after 5pm to Dr. Ostfeld or to a study representative and s/he will have text or verbal contact with the subject at least once that evening. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours.
Visit 6 Subjects will return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device with them. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be taken. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
Subjects will then receive one full day of animal-based meals (food will be provided by Montefiore-Einstein Food Services.) Subjects will be encouraged to eat breakfast at the study center after the initial anthropomorphic measures are made, saliva is obtained, and blood is drawn. Subjects will text pictures of all they consume during that day to Dr. Ostfeld and/or to a study representative and s/he will have text or verbal contact with the subject at least twice during that day. Dinner should be consumed at 8:30pm, EST. Subjects will fast other than water after 11pm. That night, subjects will do a Rigiscan™ assessment overnight at their home. Black coffee and/or tea is permitted only before noon. The time the subject goes to bed and the time the subject wakes up for the day should be recorded. The subject agrees to be in bed with Rigiscan™ on (other than for emergency or needed trips to the bathroom) for at least seven hours.
Visit 7 (End of Study) Subjects will return to the study center the morning after the Rigiscan™ assessment and bring the Rigiscan™ device with them. They will have been asked to not brush their teeth or use mouthwash and/or other breath fresheners that morning. Anthropomorphic and blood pressure and heart rate recordings will be taken. Saliva will be stored for NO measurement. Blood will be drawn and stored. Urine will be collected and stored.
Sequence Two:
Sequence Two is identical to Sequence One, except that the order of the plant-based and animal-based meals is reversed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based arm | Active Comparator | The plant-based arm consists of 3 visits to the clinical research center, following a plant-based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. |
|
| Animal-based arm | Active Comparator | The animal-based arm consists of 3 visits to the clinical research center, following an animal- based diet and using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal based diet | Other | Food will be provided by Montefiore-Einstein Food Services |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time ≥70% erect during overnight sleep after 4 meals. | Total time (in minutes) when penile rigidity is ≥ 70% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). | During overnight sleep directly after consuming the 4 meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time ≥70% erect during overnight sleep after 1 meal. | Total time (in minutes) when penile rigidity is ≥70% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Comparing heart rate by dietary pattern at both time points (after overnight sleep after consuming the 1 meal and after overnight sleep after consuming the 4 meals) and compared to its respective baseline in beats/minute. Definition: In regard to the following anthropometric, vital sign, and laboratory data (blood, urine, and saliva) pre-specified outcomes included in this pre-specified outcomes section, at "both time points" is defined as in the sentence above and "respective baseline" refers to either visit 2 or visit 5, as visit 2 is the baseline for one dietary arm (plant or animal) and visit 5 is the baseline for the other dietary arm (plant or animal). |
Inclusion Criteria:
The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
Exclusion Criteria:
Subjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and/or ADHD within 3 months of enrollment.
Subjects who have scheduled or planned medication and/or medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and/or the route of administration of a medication.
Subjects who are taking benzodiazepines and/or beta blockers
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Ostfeld, MD | Contact | 718-920-5197 | ROSTFELD@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Ostfeld, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, Department of Medicine, Division of Cardiology | Recruiting | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8254833 | Background | Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1. | |
| 19181648 | Background | Nehra A. Erectile dysfunction and cardiovascular disease: efficacy and safety of phosphodiesterase type 5 inhibitors in men with both conditions. Mayo Clin Proc. 2009 Feb;84(2):139-48. doi: 10.4065/84.2.139. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
Not provided
Not provided
| NIH |
| Dr. Irwin Goldstein | UNKNOWN |
Randomized crossover design
Not provided
Not provided
Outcomes assessor will be blinded to randomization group and order of testing.
| Plant based diet |
| Other |
Food will be provided by Montefiore-Einstein Food Services |
|
| During overnight sleep directly after consuming the 1 meal. |
| Erection events per hour during overnight sleep after 4 meals. | Total number of erection events lasting ≥5 minutes and with ≥70% rigidity at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Events/hour. | During overnight sleep directly after consuming the 4 meals. |
| Tumescence events per hour during overnight sleep after 4 meals. | Total number of tumescence events lasting ≥5 minutes and when penile circumference increases by ≥2cm at both the tip and the base of the penis compared to their respective baselines as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Tumescence events/hour | During overnight sleep directly after consuming the 4 meals. |
| Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Blood Pressure | Comparing blood pressure by dietary pattern at both time points and compared to its respective baseline in mmHg | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Weight | Comparing weight by dietary pattern at both time points and compared to its respective baseline | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Fibrinogen | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| D-dimer | Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Total cholesterol | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| HDL cholesterol | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| HDL efflux capacity | Comparing it at both time points by dietary pattern and compared to its respective baseline. | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| LDL cholesterol | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Triglyceride | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Oxidized LDL cholesterol | Comparing it at both time points by dietary pattern and compared to its respective baseline in U/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Free Fatty Acids | Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Myeloperoxidase | Comparing it at both time points by dietary pattern and compared to its respective baseline in ug/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Factor VII | Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage. | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| lysolecithin | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Apolipoprotein B | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Omega 3 index | Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage of erythrocyte fatty acid | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Lipoprotein-associated phospholipase-A2 (Lp PLA2) activity | Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/min/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Lipoprotein (a) | Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Homocysteine | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| methylmalonic acid (MMA) | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Asymmetric Dimethylarginine (ADMA) | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| symmetric dimethylarginine (SDMA) | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Total testosterone | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Sex Hormone Binding Globulin | Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| cystatin C | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| remnant cholesterol particles | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| uric acid | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| interleukin 1 | Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| interleukin 6 | Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| hsCRP | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Blood Urea Nitrogen (BUN) | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Carbon Dioxide (CO2) | Comparing it at both time points by dietary pattern and compared to its respective baseline in mmol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| creatinine | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| glucose | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| serum chloride | Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| serum potassium | Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| serum sodium | Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| alanine aminotransferase (ALT) | Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| aspartate aminotransferase (AST) | Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| estimated glomerular filtration rate (eGFR) | Comparing it at both time points by dietary pattern and compared to its respective baseline in mL/min/1.73m2 | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| vitamin c | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| reduced glutathione | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| superoxide dismutase | Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| vitamin e | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| selenium | Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| malondialdehyde | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| non coding RNA | Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| micro RNA | Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Lnc RNA | Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| trimethylamine-N-oxide (TMAO) | Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| phenylacetylglutamine (PAG) | Comparing it at both time points by dietary pattern and compared to its respective baseline in uM (micrometers) | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Comparing urine albumin-to-creatinine ratio (UACR) | Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/g | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Comparing salivary nitrite level as a correlate of plasma nitric oxide (NO) level | Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Comparing salivary nitrate level in as a correlate of plasma nitric oxide (NO) level | Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L | Time zero (Visit 2, ~1-21 days after screen), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7) |
| Percent of time ≥50% erect during overnight sleep after 4 meals. | Total time (in minutes) when penile rigidity is ≥50% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). | During overnight sleep directly after consuming the 4 meals. |
| Percent of time ≥50% erect during overnight sleep after 1 meal. | Total time (in minutes) when penile rigidity is ≥50% at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). | During overnight sleep directly after consuming the 1 meal. |
| Erection events per hour during overnight sleep after 1 meal. | Total number of erection events lasting ≥5 minutes and with ≥70% rigidity at both the tip and the base of the penis as measured by Rigiscan™ during overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Events/hour. | During overnight sleep directly after consuming the 1 meal. |
| Tumescence events per hour during overnight sleep after 1 meal. | Total number of tumescence events lasting ≥5 minutes and when penile circumference increases by ≥2cm at both the tip and the base of the penis compared to their respective baselines as measured by Rigiscan™ during overnight sleep, divided by the total time (in minutes) of overnight sleep. Overnight sleep is defined as the time in minutes from the onset of the first nocturnal erection to the end of the last nocturnal erection (as measured by Rigiscan™). This result will be reported as Tumescence events/hour. | During overnight sleep directly after consuming the 1 meal. |
| Percent of time ≥70% erect during overnight sleep after 4 meals versus after 1 meal by dietary pattern. | This outcome will evaluate whether a difference is present in the percent of time ≥70% erect during overnight sleep (as defined in outcomes above) directly after consuming the 4 meals versus directly after consuming the 1 meal by dietary pattern, for each dietary pattern. (e.g. is there a greater percentage of time ≥70% erect on the second night versus the first night when consuming the plant-based diet?). | During overnight sleep directly after consuming the 4 meals versus overnight sleep directly after consuming the 1 meal by dietary pattern, for each dietary pattern. |
| Percent of time ≥50% erect during overnight sleep after 4 meals versus after 1 meal by dietary pattern. | This outcome will evaluate whether a difference is present in the percent of time ≥50% erect during overnight sleep (as defined in outcomes above) directly after consuming the 4 meals versus directly after consuming the 1 meal by dietary pattern, for each dietary pattern. (e.g. is there a greater percentage of time ≥50% erect on the second night versus the first night when consuming the plant-based diet?). | During overnight sleep directly after consuming the 4 meals versus overnight sleep directly after consuming the 1 meal by dietary pattern, for each dietary pattern. |
| Tumescence events per hour during overnight sleep after 4 meals versus after 1 meal by dietary pattern. | This outcome will evaluate whether a difference is present in the total number of tumescence events per hour (as defined in outcomes above) directly after consuming the 4 meals versus directly after consuming the 1 meal by dietary pattern, for each dietary pattern. (e.g. is there a greater of tumescence events per hour on the second night versus the first night when consuming the plant-based diet?). | During overnight sleep directly after consuming the 4 meals versus overnight sleep directly after consuming the 1 meal by dietary pattern, for each dietary pattern. |
| 16414947 | Background | Thompson IM, Tangen CM, Goodman PJ, Probstfield JL, Moinpour CM, Coltman CA. Erectile dysfunction and subsequent cardiovascular disease. JAMA. 2005 Dec 21;294(23):2996-3002. doi: 10.1001/jama.294.23.2996. |
| 9036757 | Background | Vogel RA, Corretti MC, Plotnick GD. Effect of a single high-fat meal on endothelial function in healthy subjects. Am J Cardiol. 1997 Feb 1;79(3):350-4. doi: 10.1016/s0002-9149(96)00760-6. |
| 10609824 | Background | Ong PJ, Dean TS, Hayward CS, Della Monica PL, Sanders TA, Collins P. Effect of fat and carbohydrate consumption on endothelial function. Lancet. 1999 Dec 18-25;354(9196):2134. doi: 10.1016/s0140-6736(99)03374-7. |
| 12499333 | Background | Esposito K, Nappo F, Giugliano F, Giugliano G, Marfella R, Giugliano D. Effect of dietary antioxidants on postprandial endothelial dysfunction induced by a high-fat meal in healthy subjects. Am J Clin Nutr. 2003 Jan;77(1):139-43. doi: 10.1093/ajcn/77.1.139. |
| 17921366 | Background | Shimabukuro M, Chinen I, Higa N, Takasu N, Yamakawa K, Ueda S. Effects of dietary composition on postprandial endothelial function and adiponectin concentrations in healthy humans: a crossover controlled study. Am J Clin Nutr. 2007 Oct;86(4):923-8. doi: 10.1093/ajcn/86.4.923. |
| 20460711 | Background | Sakakibara S, Murakami R, Takahashi M, Fushimi T, Murohara T, Kishi M, Kajimoto Y, Kitakaze M, Kaga T. Vinegar intake enhances flow-mediated vasodilatation via upregulation of endothelial nitric oxide synthase activity. Biosci Biotechnol Biochem. 2010;74(5):1055-61. doi: 10.1271/bbb.90953. Epub 2010 May 7. |
| 16395320 | Background | Esposito K, Ciotola M, Giugliano F, De Sio M, Giugliano G, D'armiento M, Giugliano D. Mediterranean diet improves erectile function in subjects with the metabolic syndrome. Int J Impot Res. 2006 Jul-Aug;18(4):405-10. doi: 10.1038/sj.ijir.3901447. Epub 2006 Jan 5. |
| 19694925 | Background | Wing RR, Rosen RC, Fava JL, Bahnson J, Brancati F, Gendrano Iii IN, Kitabchi A, Schneider SH, Wadden TA. Effects of weight loss intervention on erectile function in older men with type 2 diabetes in the Look AHEAD trial. J Sex Med. 2010 Jan;7(1 Pt 1):156-65. doi: 10.1111/j.1743-6109.2009.01458.x. Epub 2009 Aug 17. |
| 21911624 | Background | Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12. |
| 26762373 | Background | Cassidy A, Franz M, Rimm EB. Dietary flavonoid intake and incidence of erectile dysfunction. Am J Clin Nutr. 2016 Feb;103(2):534-41. doi: 10.3945/ajcn.115.122010. Epub 2016 Jan 13. |
| 12789391 | Background | Yaman O, Tokath Z, Inal T, Anafarta K. Effect of sildenafil on nocturnal erections of potent men. Int J Impot Res. 2003 Apr;15(2):117-21. doi: 10.1038/sj.ijir.3900978. |
| 10318772 | Background | Corbin JD, Francis SH. Cyclic GMP phosphodiesterase-5: target of sildenafil. J Biol Chem. 1999 May 14;274(20):13729-32. doi: 10.1074/jbc.274.20.13729. No abstract available. |
| 16422962 | Background | Greenstein A, Chen J, Salonia A, Sofer M, Matzkin H, Montorsi F. Does sildenafil enhance quality of nocturnal erections in healthy young men? A NPT-RigiScan study. J Sex Med. 2004 Nov;1(3):314-7. doi: 10.1111/j.1743-6109.04045.x. |
| 2621154 | Background | Burris AS, Banks SM, Sherins RJ. Quantitative assessment of nocturnal penile tumescence and rigidity in normal men using a home monitor. J Androl. 1989 Nov-Dec;10(6):492-7. doi: 10.1002/j.1939-4640.1989.tb00148.x. |
| 26378880 | Background | Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |