NCT05957835

Brief Summary

Dietary nitrate supplementation, administered in the form of nitrate-rich beetroot juice, has been shown to improve exercise performance and may have more pronounced effects on exercise that requires high-power and high-velocity muscle contraction such as weightlifting and body-mass resisted exercise (i.e, resistance exercise). However, limited data are available that have examined the potential performance enhancing effect of beetroot juice in resistance exercise. Moreover, there is no information on the dose of nitrate required for performance enhancing effects during resistance exercise which limits its widespread use to enhance performance. Therefore, the investigators will assess if supplementing the diet with nitrate-rich beetroot juice impacts resistance exercise performance (e.g., power, velocity), when compared to supplementing the diet with nitrate-depleted beetroot juice (i.e. placebo). The investigators will also investigate the dose-response effect of beetroot juice on resistance exercise performance by providing a low, moderate, and high nitrate dose of concentrated beetroot juice. The results of this study will improve understanding of whether beetroot juice influences resistance exercise performance and will provide insight on whether different doses of beetroot juice influence the efficacy of nitrate supplementation on resistance exercise performance. Together, these data will guide supplementation strategies for enhancing resistance exercise performance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 24, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

June 28, 2023

Last Update Submit

July 16, 2023

Conditions

Outcome Measures

Primary Outcomes (15)

  • Plasma nitrate

    Plasma nitrate concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence

    Through study completion, at least 1 year

  • Plasma nitrite

    Plasma nitrite concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    Peak force will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    average propulsion force will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    rate of power development will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    peak positive power will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    concentric mean power will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    jump height will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    takeoff velocity will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    flight time will be measured using a force place.

    Through study completion, at least 1 year

  • Neuromuscular performance during countermovement jumps

    Peak force, average propulsion force, rate of power development, peak positive power, concentric mean power, jump height, takeoff velocity, flight time will be measured using a force place.

    Through study completion, at least 1 year

  • Peak power

    Power will be measured using a linear transducer with the highest value will be recorded for peak power

    Through study completion, at least 1 year

  • Mean power

    Power will be measured using a linear transducer and will be averaged across sets for the determination of mean power

    Through study completion, at least 1 year

  • Mean velocity

    Velocity will be measured using a linear transducer and will be averaged across sets for the determination of mean velocity

    Through study completion, at least 1 year

  • Peak velocity

    Velocity will be measured using a linear transducer the highest value will be retained for peak velocity

    Through study completion, at least 1 year

Secondary Outcomes (1)

  • Mood

    Through study completion, at least 1 year

Study Arms (4)

BR-HIGH

EXPERIMENTAL

Participants will ingest an elevated dose of nitrate 2.5 hours prior to exercise.

Dietary Supplement: BR-HIGH

BR-MOD

EXPERIMENTAL

Participants will ingest a moderate dose of nitrate 2.5 hours prior to exercise.

Dietary Supplement: BR-MOD

BR-LOW

EXPERIMENTAL

Participants will ingest a low dose of nitrate 2.5 hours prior to exercise.

Dietary Supplement: BR-LOW

PL

PLACEBO COMPARATOR

Participants will ingest a negligible amount of nitrate 2.5 hours prior to exercise.

Dietary Supplement: PL

Interventions

BR-HIGHDIETARY_SUPPLEMENT

4 x nitrate-rich beetroot juice shots (26 mmol of nitrate)

BR-HIGH
BR-MODDIETARY_SUPPLEMENT

2 x nitrate-rich beetroot juice shots + 2 x nitrate-depleted beetroot juice shot (12 mmol of nitrate)

BR-MOD
BR-LOWDIETARY_SUPPLEMENT

1 x nitrate-rich beetroot juice shot + 3 x nitrate-depleted beetroot juice shots (6 mmol of nitrate)

BR-LOW
PLDIETARY_SUPPLEMENT

4 x nitrate-depleted beetroot juice shots (0 mmol of nitrate)

PL

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFemales were excluded given that sex-differences in the physiological responses to nitrate ingestion may exist and that including the appropriate controls (i.e., testing only during the early follicular phase) would have been unfeasible logistically.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active males who performed resistance exercise at least twice weekly for the last two years

You may not qualify if:

  • individuals with contraindications to exercise, cardiometabolic disease, currently consuming dietary supplements containing caffeine, sodium bicarbonate, creatine, beta-alanine, and/or NO precursor supplements (i.e., NO3-, arginine, citrulline, antioxidants), females, and smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pepperdine University

Malibu, California, 90263, United States

RECRUITING

Study Officials

  • Rachel Tan, PhD

    Pepperdine University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The lead researcher, data collectors, and participants were blinded to the conditions. The distribution of supplements for each condition was performed by a researcher that was not formally involved in data collection processes, thereby limiting the potential of bias.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: In a double-blind, randomised, crossover design, participants were assigned to four experimental trials to consume a total of 4 beetroot juice shots during each condition: (a) 4 x 70 ml of nitrate-depleted beetroot juice for placebo (PL), (b) 1 x 70 ml of nitrate-rich beetroot juice 3 x 70 ml nitrate-depleted beetroot juice for a low dose of nitrate-rich beetroot juice (BR-LOW; \~6.5 mmol of nitrate total), (c) 2 x 70 of nitrate-rich beetroot juice and 2 x 70ml of nitrate depleted beetroot juice for a moderate dose of nitrate-rich beetroot juice (BR-MOD; \~13 mmol of nitrate total), and (d) 4 x 70 ml of nitrate-rich beetroot juice for an elevated dose of nitrate-rich beetroot juice (BR-HIGH; \~26 mmol of nitrate total).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Sports Medicine

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 24, 2023

Study Start

May 23, 2023

Primary Completion

April 28, 2024

Study Completion

June 30, 2024

Last Updated

July 24, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation, upon request.

Locations