NCT06274385

Brief Summary

Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 6, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

February 6, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

betalainsbeetrootrepeated sprint performancesupplement

Outcome Measures

Primary Outcomes (2)

  • Repeated Sprint Performance

    Absolute and relative measures of peak, average, and minimum power (Watts). Also, the time to peak power and average power during the first and second half of each 30 s sprint.

    Each data point will be assessed immediately after each Wingate sprint

  • Repeated Sprint Performance

    Fatigue index (%)

    Each data point will be assessed immediately after each Wingate sprint

Secondary Outcomes (1)

  • Neuromuscular Fatigue

    Pre-repeated sprint exercise, immediately post-repeated sprint exercise, and 5 minutes post-repeated sprint exercise

Study Arms (2)

Betalain-rich Concentrate

EXPERIMENTAL

A single dose of a BRC supplementation

Dietary Supplement: Betalain-rich concentrate (AltRed)

Placebo

PLACEBO COMPARATOR

A single dose of a placebo

Other: Placebo

Interventions

A single dose of 100 mg (2 x 50 mg) 120 min before exhaustive exercise. Supplement instructions: All treatments will be administered in similar capsules (smell, color, and size) to ensure both the participants and researcher are blinded to the treatment. All treatments will be administered in an opaque lidded container. The participants will be instructed to close their eyes and carefully open the container, keeping their heads forward. They will be asked to place the container to their lips, tipping the container to pour the contents into their mouth. Immediately after, they will be instructed to drink water to help them swallow the pill and instructed not to chew or manipulate the pill inside their mouth.

Betalain-rich Concentrate
PlaceboOTHER

A single dose (2 x empty capsules) 120 min before exhaustive exercise. Supplement instructions: All treatments will be administered in similar capsules (smell, color, and size) to ensure both the participants and researcher are blinded to the treatment. All treatments will be administered in an opaque lidded container. The participants will be instructed to close their eyes and carefully open the container, keeping their heads forward. They will be asked to place the container to their lips, tipping the container to pour the contents into their mouth. Immediately after, they will be instructed to drink water to help them swallow the pill and instructed not to chew or manipulate the pill inside their mouth.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, recreationally active males and females
  • Aged 18-40
  • Free of disease or injury

You may not qualify if:

  • Have any musculoskeletal injuries that could be made worse by participating in this study (e.g., sprain or strain of lower limb)
  • Have documented medical conditions (i.e., hypertension, asthma, heart disease, diabetes) or exhibit signs and symptoms of medical conditions
  • Taking any medication that would interfere with the interpretation of our results. These include, but are not limited to, anti-inflammatory drugs, antibiotics, anti-hypertensives, and any medicine controlling the digestive system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University - Health Sciences Building

Philadelphia, Pennsylvania, 19102, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 23, 2024

Study Start

March 6, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations