Dietary Nitrate and Muscle Power With Aging
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|ClinicalTrials.gov Identifier: NCT03513302|
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aging Sarcopenia||Dietary Supplement: placebo Dietary Supplement: nitrate||Phase 1|
Hide Detailed Description
This study consists of two parts separated by a 14 day wash-out. Subjects will be randomly assigned to receive either the BRJ or placebo during the first part. During the second part they will receive the opposite of what they had during the first part. This is considered a double-blind study, which means neither the subjects nor the investigators will know what form (BRJ or placebo) a subject is receives.
Study Visit One (Screening) 1-2 hours
The purpose of the screening visit is to explain all aspects of the study. It will also determine if subjects can participate in the study. Subjects will provide a complete medical history and undergo a physical exam. They will have their blood drawn (about 1.5 teaspoons) and provide a urine sample. They will also practice the entire neuromuscular function exercise test. During this test, the strength of their muscles will be determined by having them kick, push and/or pull back as hard as you can while their leg is strapped to an exercise device. A vital signs monitor will measure your blood pressure, heart rate, and rhythm.
During the remainder of the study subjects will be instructed to consume their normal diet. 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. Chewing gum, alcohol, and food and drinks containing caffeine (coffee, tea, chocolate, and soft drinks) should be avoided 24 hours prior to each visit. 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 6 mL or about 1.2 teaspoons. The first blood draw will check nitrate and nitrite levels. They will then have a breath test to check nitric oxide. They will then drink 140 mL (about 2/3 of a cup) of BRJ (or placebo). 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. Subjects will then rest quietly in a private room for about 2 hours after ingestion of BRJ (or placebo) then will perform:
- The neuromuscular function test that was practiced during the screening visit.
- After completing the exercise test they will undergo a muscle biopsy of their thigh muscle. First, the area will be sterilized and numbed with an injection. Next, a small incision (about ¼ inch) will be made and a small biopsy needle will be used to collect a small sample of your muscle (about the size of a pencil eraser). This will be performed on the leg opposite of that used during the neuromuscular test.
- One final blood and breath sample will then be obtained.
- Subjects will then be provided a 7 day supply of BRJ (or placebo) and will continue to drink two bottles (about 5 oz) every morning.
- Subjects will also be provided with an activity tracker. This will be worn at the hip during all waking hours except when bathing or swimming. This monitor will measure total activity time and sedentary time.
Study Visit Three - 1-2 hours
Subjects will return to the research center with the empty BRJ bottles. At this visit a single blood (1.2 teaspoon) and breath sample will be collected. Subjects will then complete a questionnaire to rate how tired they felt during the previous week. They will be provided another 7 day supply of BRJ (or placebo) and will continue to drink two bottles every morning.
Study Visit Four - Approximately 5 hours Subjects will return to the research center and undergo the same procedures as they did in Study Visit Two. They will also complete a questionnaire that will rate how tired they felt during the previous week.
Washout After visit four subjects will undergo a 14 day washout period where they will not drink the BRJ (or placebo). There are no dietary restrictions at this time; subjects may consume caffeine, alcohol, gum, mouthwash, etc. Subjects will then repeat Study Visits Two, Three, and Four again. However, during this they will be given the opposite form of BRJ you had received before.
Study Visit Five Subjects will repeat the procedures completed during Study Visit Two.
Study Visit Six Subjects will repeat the procedures completed during Study Visit Three.
Study Visit Seven Subjects will repeat the procedures completed during Study Visit Four.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled, crossover|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Dietary Nitrate and Muscle Power With Aging|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
|Placebo Comparator: placebo||
Dietary Supplement: placebo
2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.
Other Name: Beet It Sport Nitrate 400 placebo
|Active Comparator: nitrate||
Dietary Supplement: nitrate
2 x 70 mL concentrated beet root juice per day for 14 days.
Other Name: Beet It Sport Nitrate 400
- Muscle function [ Time Frame: 1 day ]Maximal knee extensor speed and power determined using isokinetic dynamometry
- Muscle function [ Time Frame: 14 days ]Maximal knee extensor speed and power determined using isokinetic dynamometry
- Muscle cGMP [ Time Frame: 1 day ]Muscle cyclic guanosine monophosphate concentration
- Muscle cGMP [ Time Frame: 14 days ]Muscle cyclic guanosine monophosphate concentration
- Plasma nitrate [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]Plasma nitrate concentrations
- Plasma nitrite [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]Plasma nitrite concentrations
- Breath nitric oxide [ Time Frame: 0,1,2,3 hours after treatment at 1 and 14 days ]Breath nitric oxide level
- Perceived fatigue [ Time Frame: 1,7,14 days of treatment ]Perceived fatigue questionnaire (PROMIS 8a)
- Physical function [ Time Frame: 1,7,14 days of treatment ]Physical function questionnaire (PROMIS 20a)
- Physical activity [ Time Frame: 1,7,14 days of treatment ]Physical activity (total and bouted) from ActiGraph monitors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513302
|Contact: Richard L Hoffman, MSemail@example.com|
|United States, Indiana|
|Indiana University School of Health and Human Sciences||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Richard L Hoffman, MS 317-274-0648 firstname.lastname@example.org|
|Principal Investigator:||Andrew Coggan, PhD||Indiana University School of Medicine|