- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274385
The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery. (BET_RSE)
The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery: A Randomized, Double-blind, Crossover, Placebo-control Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A minimum of 10 recreationally active men and women will be recruited from the Drexel University student population. All eligible participants will report to the laboratory for a total of three visits (one familiarization session, and two testing sessions). Each participant will be randomly assigned to receive the treatment or placebo in a counterbalanced fashion.
Visit 1 will serve as a familiarization session, where all participants will perform the repeated-sprint exercise (RSE) protocol, and the countermovement jump (CMJ) to become acquainted with the exercises. In addition to testing familiarization, baseline characteristics will be obtained (i.e., height, weight, and body composition).
Visits 2 and 3 will serve as the testing sessions. All participants will report to the laboratory in the morning, no earlier than 48 hours after Visit 1, following an overnight fast of at least eight hours before arriving. During the fasting period, participants will be asked to avoid all food and drinks except water, which can be consumed ad libitum. Upon arrival, participants will be given a 10-minute seated rest period, during which they will be fitted with a Polar heart rate monitor to assess heart rate (HR). After the 10 min rest period, participants will receive their designated supplement, and then sit quietly for 20 min. Afterward, participants will be given a standardized snack (Clif Builder's Bar; kcals: 270, fat: 8g, carbs: 30g, protein: 20g) and 500 ml of water, then sit quietly for an additional 100 min.
At 120 min post-treatment, HR, muscle soreness (MS), and rate of perceived exertion (RPE) will be obtained. The participants will then be asked to begin the warmup, which will consist of 10 min of cycling at a resistance of 60 W. Immediately prior to the RSE, all participants will perform three CMJs. Once done, the participants will perform the RSE protocol, consisting of three back-to-back 30-second Wingate tests, each interspersed by 2 min.
After sprints 1 and 2, peak power (PP), average power (AP), fatigue index (FI), RPE, MS, and HR, will be obtained. Immediately following the RSE (i.e., sprint 3), participants will perform the CMJs again, and PP, AP, FI, MS, and HR will be recorded. Final CMJ measures will be taken 5 min following the RSE.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Recruiting
- Drexel University - Health Sciences Building
-
Contact:
- Arun Ramakrishnan, PhD
- Phone Number: 215-553-7018
- Email: ar88@drexel.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy, recreationally active males and females
- Aged 18-40
- Free of disease or injury
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Betalain-rich Concentrate
A single dose of a BRC supplementation
|
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. |
|
Placebo Comparator: Placebo
A single dose of a placebo
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repeated Sprint Performance
Time Frame: Each data point will be assessed immediately after each Wingate sprint
|
Fatigue index (%)
|
Each data point will be assessed immediately after each Wingate sprint
|
|
Repeated Sprint Performance
Time Frame: Each data point will be assessed immediately after each Wingate sprint
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuromuscular Fatigue
Time Frame: Pre-repeated sprint exercise, immediately post-repeated sprint exercise, and 5 minutes post-repeated sprint exercise
|
Countermovement Jump (average of three jumps; cm)
|
Pre-repeated sprint exercise, immediately post-repeated sprint exercise, and 5 minutes post-repeated sprint exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2311010178
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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