The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance

May 13, 2019 updated by: Edward Bitok, Loma Linda University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

A randomized controlled double-blind crossover study with a baseline and two interventions. On day 1 (baseline), all subjects will have a lactate fingerstick measurement before and after the Wingate protocol. A random subsample (1/3 of subjects) will have 10 milliliters (2 teaspoon) of blood drawn for determination of serum allantoin. Subjects will then be equipped with a pulse oximeter and a heart rate monitor after which they will perform the Wingate Anaerobic test protocol. The protocol includes: 4 minutes of warm up, 3 seconds of warm up sprint with weights, 1-minute relaxed cycling, 2-minute rest, then 10 seconds cycling without weights. This will be followed by 30 seconds sprint with weights and end with 2 minutes of relaxed cycling. A post-activity blood draw will be performed for another 10 milliliters (2 teaspoon) of blood from the same one-third of subjects previously sampled. After baseline data collection, subjects will undergo a 1-week washout (avoiding high antioxidant foods) after which they will be randomized to treatment groups. On day 9, subjects will begin supplementation with nitrate from beetroot powder with additional anthocyanins, or nitrate from beetroot powder with a placebo for 7 days. On day 15 the subject will again repeat the same procedures as day 1, followed by another week of washout. They will supplement again on day 23 and repeat the same procedure as the first intervention on day 29.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: beetroot and anthocyanin
A 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 anthocyanin will be taken for 7 days during the study two hours prior to eating.
Placebo Comparator: beetroot and placebo
The 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.
Beetroot and placebo will be taken for 7 days during the study two hours prior to eating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood lactate levels
Time Frame: Day 1
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
Time Frame: Day 15
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
Time Frame: Day 29
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allantoin blood level
Time Frame: Baseline, day 15, and day 29
Non-fasting blood tests will be done for allantoin during baseline, intervention I, and intervention II.
Baseline, day 15, and day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edward Bitok, DrPH, Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 5180190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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