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| Name | Class |
|---|---|
| Beyond Meat | UNKNOWN |
| San Diego Sexual Medicine | OTHER |
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The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.
Visit 1 (Screening Visit):
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.
If the STOP-BANG score identified intermediate or high risk for OSA, subjects will be advised to contact their primary care provider.
If the subject has insomnia, the subject will be given the recommendation 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 their 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 when food is provided (see below).
Sequence One:
Visit 2:
Subjects will return to the study center. Subjects will be asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be made.
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 will consume their usual diet until 4pm EST. Water will be the only beverage allowed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 3:
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
There will then be a washout period for 5-8 days and subjects will be instructed to return to their usual dietary habits during this washout period.
Visit 4:
After the washout period, subjects will return to the study center. Subjects will have been asked not to use mouthwash and/or other breath fresheners that day. Anthropomorphic and blood pressure and heart rate recordings will be taken.
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 4pm EST. Water will be the only beverage consumed after 4pm. Dinner should be consumed at 8:30pm, EST. 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. After consuming the dinner, subject will only drink/consume water until the end of Rigiscan recording (at least 7 hours).
Visit 5 (End of Study):
Subjects will return to the study center the day after the Rigiscan™ assessment and bring the Rigiscan™ device with them. Anthropomorphic and blood pressure and heart rate recordings will be made.
Sequence Two is identical to Sequence One, except that the order of the plant-based and animal-based meals is reversed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based | Active Comparator | The plant-based arm consists of consuming one plant-based meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat. |
|
| Animal-based | Active Comparator | The animal-based arm consists of consuming one animal meat meal and then using the Rigiscan™ device to measure the frequency, rigidity, and duration of nocturnal erections. The meal in the plant-based arm and the meal in the animal-based arm will differ only by whether the meal contains plant-based meat or animal meat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal-based meal | Other | Consuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of time with ≥70% erection 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™). | During overnight sleep directly after consuming the 1 meal. Up to 7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Erection Events/hour. |
| 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 compared to its respective baseline in beats/minute. | Pre and post overnight Rigiscan recording. Up to 7 months. |
| Blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Ostfeld, MD, MSc | Contact | 718-920-5197 | ROstfeld@Montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Ostfeld, MD, MSc | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Randomized crossover design
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Outcomes assessor will be blinded to randomization group and order of testing.
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| Plant-based meat meal | Other | Consuming a single plant-based meat or a single animal meat meal and measuring the meals impact on erectile function with the Rigiscan™ device. |
|
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| During overnight sleep directly after consuming the 1 meal. Up to 7 months. |
| 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. Up to 7 months. |
Comparing blood pressure (both systolic and diastolic) by dietary pattern at both time points after overnight sleep after consuming the 1 meal and compared to its respective baseline in mmHg.
| Pre and post overnight Rigiscan recording. Up to 7 months. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |