The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of this graduate student research study is to investigate the effects of nitrate from beetroot powder with additional anthocyanins from tart cherry on exercise performance in healthy Loma Linda University students utilizing the Wingate Anaerobic test on stationary bike.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMay 15, 2019
May 1, 2019
7 months
June 19, 2018
May 13, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Change in blood lactate levels
Participants in this study should reach an anaerobic state as they perform the Wingate test. This lactate pro analyzer will be a tool to examine the participant's change in blood lactate levels by means of POC fingertip lactate measurement. Lactate levels will be measured in all participants at baseline, before and after Wingate Anaerobic test.
Day 1
Change in blood lactate levels
Participants in this study should reach an anaerobic state as they perform the Wingate test. This lactate pro analyzer will be a tool to examine participant's change in blood lactate levels by means of POC fingertip lactate measurement. Lactate levels will be measured in all participants at intervention I, before and after Wingate Anaerobic test.
Day 15
Change in blood lactate levels
Participants in this study should reach an anaerobic state as they perform the Wingate test. This lactate pro analyzer will be a tool to examine participant's change in blood lactate levels by means of POC fingertip lactate measurement. Lactate levels will be measured in all participants at intervention II, before and after Wingate Anaerobic test.
Day 29
Secondary Outcomes (1)
Allantoin blood level
Baseline, day 15, and day 29
Study Arms (2)
beetroot and anthocyanin
EXPERIMENTALA compound pharmacy will formulate capsules with nitrates extracted from beetroot and anthocyanins from tart cherries. A daily dose of the capsules will be taken for 7 days after the washout period. Each dose will comprise 500 mg of nitrates and 450 mg of anthocyanins. In a meta-review by Dominguez and colleagues, 6-8 mmol of nitrates from beetroot was associated with increased exercise performance. Another review by Kelley et al., showed that marathon runners and resistance trainers ingesting between 450-480 mg of anthocyanins had reduced muscle soreness and decreased oxidative stress. Subject will consume each supplement orally with only water 2 hours pre-prandial.
beetroot and placebo
PLACEBO COMPARATORThe same compound pharmacy will formulate capsules with nitrate extracted from beetroot and a placebo element made of starch. This product will taste the same as the nitrate and anthocyanin supplementation. A daily dose of the capsules will be taken for 7 days after the washout period. Each supplementation will have 500 mg of nitrate and 450 mg of placebo. Subjects will consume each supplement orally with only water 2 hours pre-prandial.
Interventions
Beetroot and anthocyanin will be taken for 7 days during the study two hours prior to eating.
Beetroot and placebo will be taken for 7 days during the study two hours prior to eating.
Eligibility Criteria
You may qualify if:
- Healthy Loma Linda University students aged between 21 and 35 years old
- Willing to abstain from caffeine, mouthwash, chewing gums, and high antioxidant foods during the week of supplementation.
You may not qualify if:
- Diabetic
- having salivary gland disorder, cardiovascular disease or orthopedic injuries
- pregnant or breastfeeding
- taking NSAIDS
- have an allergy to anthocyanins and/or beetroot
- women who are on their menses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda Universtiy
Loma Linda, California, 92350, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Bitok, DrPH
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 19, 2018
First Posted
August 15, 2018
Study Start
September 1, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
May 15, 2019
Record last verified: 2019-05