Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Nitrate is a naturally-occurring substance found in foods, especially green leafy vegetables and beets. Increasing nitrate intake (by drinking beetroot juice (BRJ) has been shown to improve muscle function young and middle-aged subjects, athletes, and patients with heart failure. The purpose of this study is to determine whether dietary nitrate provides a similar benefit in older individuals, and if so, the optimal dose. We will be comparing the effects of ingesting BRJ containing a smaller or greater amount of nitrate versus the effects of a placebo (BRJ from which the nitrate has been removed).
This study consists of four visits that will take a minimum of 15 days to complete.
Study Visit One (Screening) 1-2 hours The purpose of the screening visit is to explain all aspects of the study. The investigators will also determine if individuals can participate in the study. Eligible subjects will undergo a complete medical history and physical exam. They will have their blood drawn, and will provide a urine sample (to determine if they are pregnant). Subjects will also practice the entire neuromuscular function exercise test. During this test, the strength of the subject's muscles will be determined by having them kick, push and/or pull back as hard as they can while their leg is strapped to an exercise device. Blood pressure and heart rate and rhythm will be monitored.
Subjects will be instructed to consume their normal diet throughout the study. However, they will be asked to avoid eating foods high in nitrate such as beets, spinach, and collard greens the evening before each visit. They will be asked to refrain from the use of antibacterial mouthwash, such as Listerine or Cepacol, during the study. Subjects will also be asked to not chew gum or to consume alcohol or food and drinks that contain caffeine for 24 hour before each visit. This includes coffee, tea, chocolate and soft drinks such as Mountain Dew. Finally, they will be asked to fast for 12 hour prior to each study visit.
Study Visit Two - Approximately 5 hours At the beginning of this visit a catheter (small, flexible, sterile plastic tube) will be placed through a vein in one of the subject's arms. This is for collection of blood samples. Blood will be drawn four times during this visit. Each draw will be 6mL or about 1.2 teaspoons. The first blood draw will check nitrate and nitrogen levels. Subjects will then have a breath test to check nitric oxide. They will then drink about 280 mL (about 1 cup) of BRJ. In one trial, this will be a placebo, that is, BRJ from which the essentially all of the nitrate has been removed. In another trial, they will drink BRJ still containing nitrate. In a third trial, they will drink an equal mixture of the placebo and nitrate-containing BRJ. Blood and breath samples will be obtained every hour. Heart rate and blood pressure will be measured at the same times the blood and breath samples are obtained. About 2 hours after ingestion of BRJ (or placebo) subjects will be asked to perform the neuromuscular function test that was practiced during the screening visit. After completing the exercise test one final blood and breath sample will be obtained.
Study Visits Three and Four
The same procedures completed during Study Visit Two will be performed. The order of treatment (placebo vs. lower dose vs. higher dose of nitrate) will be randomized using a computer program. Neither the subjects nor the investigators will know the treatment they receive during each visit until the entire study is completed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3.3 mL/kg concentrated beet root juice *depleted of nitrate* Other names: Beet It Sport Nitrate 400 placebo |
|
| low nitrate | Active Comparator | 1.55 mL/kg concentrated beet root juice depleted of nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* Other names: Beet It Sport Nitrate 400 placebo + Beet It Sport Nitrate 400 |
|
| high nitrate | Active Comparator | 3.3 mL/kg concentrated beet root juice containing nitrate Other names:Beet It Sport Nitrate 400 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beet root juice | Dietary Supplement | Beet root juice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Knee Extensor Velocity | Maximal knee extensor velocity determined using isokinetic dynamometry | 1 day |
| Maximal Knee Extensor Power | Maximal knee extensor power determined using isokinetic dynamometry | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nitrite | 0, 1, 2, 3 h after ingestion | |
| Plasma Nitrate | 0, 1, 2, 3 h after ingestion | |
| Breath Nitric Oxide |
Not provided
Inclusion Criteria:
• In good health, as determined by the investigator's review of history (provided by subject at screening visit), physical examination, and routine blood and urine tests (done at screening visit)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew R Coggan, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Health and Human Sciences | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29547495 | Background | Coggan AR. Dietary Nitrate and Muscle Function in Humans: Acute versus Chronic Mechanisms. Med Sci Sports Exerc. 2018 Apr;50(4):874. doi: 10.1249/MSS.0000000000001489. No abstract available. | |
| 28916479 | Background | Coggan AR, Broadstreet SR, Mahmood K, Mikhalkova D, Madigan M, Bole I, Park S, Leibowitz JL, Kadkhodayan A, Thomas DP, Thies D, Peterson LR. Dietary Nitrate Increases VO2peak and Performance but Does Not Alter Ventilation or Efficiency in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2018 Feb;24(2):65-73. doi: 10.1016/j.cardfail.2017.09.004. Epub 2017 Sep 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Low Then High | 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day) |
| FG001 | Low Then High Then Placebo | 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| FG002 | High Then Placebo Then Low | 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day)washout (7 days),1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| FG003 | High Then Low Then Placebo | 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days),3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Low Then High | 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Knee Extensor Velocity | Maximal knee extensor velocity determined using isokinetic dynamometry | Posted | Mean | Standard Deviation | rad/s | 1 day |
|
2 wk (during study participation)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants/Arms | All study participants/arms | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew R. Coggan | Indiana University Purdue University Indianapolis | 3172740656 | acoggan@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2019 | Jun 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2019 | Jun 28, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Double-blind, placebo-controlled, crossover
Not provided
Not provided
Not provided
| 0, 1, 2, 3 h after ingestion |
| 27271563 | Background | Coggan AR, Peterson LR. Dietary Nitrate and Skeletal Muscle Contractile Function in Heart Failure. Curr Heart Fail Rep. 2016 Aug;13(4):158-65. doi: 10.1007/s11897-016-0293-9. |
| 26641379 | Background | Rimer EG, Peterson LR, Coggan AR, Martin JC. Increase in Maximal Cycling Power With Acute Dietary Nitrate Supplementation. Int J Sports Physiol Perform. 2016 Sep;11(6):715-720. doi: 10.1123/ijspp.2015-0533. Epub 2016 Aug 24. |
| 26179185 | Background | Coggan AR, Leibowitz JL, Spearie CA, Kadkhodayan A, Thomas DP, Ramamurthy S, Mahmood K, Park S, Waller S, Farmer M, Peterson LR. Acute Dietary Nitrate Intake Improves Muscle Contractile Function in Patients With Heart Failure: A Double-Blind, Placebo-Controlled, Randomized Trial. Circ Heart Fail. 2015 Sep;8(5):914-20. doi: 10.1161/CIRCHEARTFAILURE.115.002141. Epub 2015 Jul 15. |
| 25199856 | Background | Coggan AR, Leibowitz JL, Kadkhodayan A, Thomas DP, Ramamurthy S, Spearie CA, Waller S, Farmer M, Peterson LR. Effect of acute dietary nitrate intake on maximal knee extensor speed and power in healthy men and women. Nitric Oxide. 2015 Aug 1;48:16-21. doi: 10.1016/j.niox.2014.08.014. Epub 2014 Sep 6. |
| screen failure |
|
| BG001 |
| Low Then High Then Placebo |
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| BG002 | High Then Placebo Then Low | 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| BG003 | High Then Low Then Placebo | 3.3 mL/kg concentrated beet root juice containing nitrate (1 day)washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice *depleted of nitrate* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice *depleted of nitrate* (1 day) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| High Nitrate |
3.3 mL/kg concentrated beet root juice containing nitrate (1 day) Other names: Beet It Sport Nitrate 400 Beet root juice: Beet root juice |
|
|
|
| Primary | Maximal Knee Extensor Power | Maximal knee extensor power determined using isokinetic dynamometry | Posted | Mean | Standard Deviation | W/kg | 1 day |
|
|
|
|
| Secondary | Plasma Nitrite | Posted | Mean | Standard Deviation | umol/L | 0, 1, 2, 3 h after ingestion |
|
|
|
|
| Secondary | Plasma Nitrate | Posted | Mean | Standard Deviation | umol/L | 0, 1, 2, 3 h after ingestion |
|
|
|
|
| Secondary | Breath Nitric Oxide | Posted | Mean | Standard Deviation | ppm | 0, 1, 2, 3 h after ingestion |
|
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
|
| 2 h |
|
| 3 h |
|
|
| 2 h |
|
| 3 h |
|
|
| 2 h |
|
| 3 h |
|