NCT03631394

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

June 19, 2018

Last Update Submit

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

EXPERIMENTAL

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.

Other: beetroot and anthocyanin

beetroot and placebo

PLACEBO COMPARATOR

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.

Other: beetroot and placebo

Interventions

Beetroot and anthocyanin will be taken for 7 days during the study two hours prior to eating.

beetroot and anthocyanin

Beetroot and placebo will be taken for 7 days during the study two hours prior to eating.

beetroot and placebo

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Study Officials

  • Edward Bitok, DrPH

    Loma Linda University

    PRINCIPAL INVESTIGATOR

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

Locations