NutraceuticalsBET_RSENCT06274385
The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery.
A study testing Betalain-rich concentrate (AltRed) in people with Nutraceuticals, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutraceuticals
- What is being tested?
- Betalain-rich concentrate (AltRed)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, recreationally active males and females
- Aged 18-40
- Free of disease or injury
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Drexel University - Health Sciences Building
Philadelphia, Pennsylvania, 19102
Arun Ramakrishnan, PhD, 215-553-7018, ar88@drexel.edu
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Nutraceuticals
- Being tested
- Betalain-rich concentrate (AltRed), Placebo
- Keywords
- betalains, beetroot, repeated sprint performance, supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betalain-rich concentrate (AltRed)Dietary supplement
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Betalain-rich Concentrate | Experimental | A single dose of a BRC supplementation Receives: Dietary Supplement: Betalain-rich concentrate (AltRed) |
| Placebo | Placebo comparator | A single dose of a placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each data point will be assessed immediately after each Wingate sprint
Repeated Sprint Performance
Fatigue index (%)
Measured: Each data point will be assessed immediately after each Wingate sprint
Secondary outcomes (1)
Neuromuscular Fatigue
Countermovement Jump (average of three jumps; cm)
Measured: Pre-repeated sprint exercise, immediately post-repeated sprint exercise, and 5 minutes post-repeated sprint exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start6 Mar 2024
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutraceuticalsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274385
- Sponsor's protocol ID
- 2311010178
- Acronym
- BET_RSE
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06274385
- Acronym / sponsor ID
- BET_RSE / 2311010178
- Conditions
- Nutraceuticals
- Keywords
- betalains, beetroot, repeated sprint performance, supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betalain-rich Concentrate | Experimental | Dietary Supplement: Betalain-rich concentrate (AltRed)A single dose of a BRC supplementation |
| Placebo | Placebo comparator | Other: PlaceboA single dose of a placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, recreationally active males and females
- Aged 18-40
- Free of disease or injury
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betalain-rich concentrate (AltRed)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. | Dietary supplement | Betalain-rich Concentrate |
| PlaceboA 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. | Other | Placebo |
Primary outcome
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.
Repeated Sprint Performance
Time frame: Each data point will be assessed immediately after each Wingate sprint
Fatigue index (%)
1 secondary outcome
Neuromuscular Fatigue
Time frame: Pre-repeated sprint exercise, immediately post-repeated sprint exercise, and 5 minutes post-repeated sprint exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betalain-rich concentrate (AltRed) in people with Nutraceuticals, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated Sprint Performance (time frame: Each data point will be assessed immediately after each Wingate sprint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.