Exercise-induced Delayed Onset Muscle SorenessNCT01781910
Branched Chain Amino Acid Plus Glucose Supplement Reduces Exercise-Induced Delayed Onset Muscle Soreness in College Females
A study testing Branched Chain Amino Acid drink supplement in people with Exercise-induced Delayed Onset Muscle Soreness, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to determine if a dietary supplement containing branched chain amino acids will reduce the muscle soreness that sometimes occurs in the days following exercise. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Delayed Onset Muscle Soreness
- What is being tested?
- Branched Chain Amino Acid drink supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men (n=9) and women (n=11) aged 18-25 who engaged in no more than one hour of light to moderate intensity physical activity per week were recruited from the Greater Burlington, Vermont area.
Who cannot join
- individuals who engaged in more than one hour per week of light to moderate physical activity
- had been involved in strict athletic competition or weight training in the past six months
- were pregnant or nursing, had a known muscular disease, diabetes mellitus, cardiovascular disease, respiratory disease, and/or were currently taking a protein-based dietary supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Branched Chain Amino Acid and Nutrient Supplementation on Exercise-Induced Delayed Onset Muscle Soreness in College Females
The purpose of this study is to determine if a dietary supplement containing branched chain amino acids will reduce the muscle soreness that sometimes occurs in the days following exercise.
Read the detailed description
Supplementation with branched chain amino acids (BCAAs) has been used to stimulate muscle protein synthesis following exercise. The purpose of this study was to determine if supplementation with BCAAs in combination with glucose would reduce exercise-induced delayed onset muscle soreness (DOMS). Using a double-blind crossover design, 20 subjects (11 females, 9 males) were randomly assigned to either BCAA (n=10) or placebo (n=10) groups. Subjects performed a squatting exercise to elicit DOMS and rated their muscle soreness every 24 hours for four days following exercise while continuing to consume the BCAA or placebo. Following a three-week recovery period, subjects returned and received the alternate BCAA or placebo treatment, repeating the same exercise and DOMS rating protocol for the next four days. BCAA supplementation in female subjects resulted in a significant decrease in DOMS versus placebo at 24 hours following exercise (p = 0.018). No significant effect of BCAA supplementation versus placebo was noted in male subjects, nor when male and female results were analyzed together. This gender difference may be related to dose per body weight differences between male and female subjects.
- Being tested
- Branched Chain Amino Acid drink supplement, Placebo
- Keywords
- branched chain amino acids, exercise, delayed onset muscle soreness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched Chain Amino Acid drink supplementDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Branch Chain Amino Acid supplement | Experimental | A drink supplement containing 1.22 grams of branched chain amino acids, plus glucose. Receives: Dietary Supplement: Branched Chain Amino Acid drink supplement |
| Placebo supplement | Placebo comparator | The placebo was formulated to match both the taste and color of the test supplement. Crystal Light Lemonade powder (Kraft Foods, Northfield, IL, USA) was mixed with 5.6g of powdered dextrose (Now Foods, Bloomingdale, IL, USA) to match the amount of dextrose present in the BCAA supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Onset Muscle Soreness Rating Scale
Measured: Every 24 hours for four days following exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startSep 2011
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced Delayed Onset Muscle SorenessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Pintauro, University of Vermont
- Investigators
- Stephen J Pintauro, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781910
- Sponsor's protocol ID
- CHRMS M12-101
- Status last verified
- Jan 2013
- First submitted
- 30 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Branched Chain Amino Acid and Nutrient Supplementation on Exercise-Induced Delayed Onset Muscle Soreness in College Females
- ClinicalTrials.gov ID
- NCT01781910
- Acronym / sponsor ID
- CHRMS M12-101
- Keywords
- branched chain amino acids, exercise, delayed onset muscle soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- First posted
- 1 Feb 2013 (estimated)
- 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.
The purpose of this study is to determine if a dietary supplement containing branched chain amino acids will reduce the muscle soreness that sometimes occurs in the days following exercise.
Detailed description
Supplementation with branched chain amino acids (BCAAs) has been used to stimulate muscle protein synthesis following exercise. The purpose of this study was to determine if supplementation with BCAAs in combination with glucose would reduce exercise-induced delayed onset muscle soreness (DOMS). Using a double-blind crossover design, 20 subjects (11 females, 9 males) were randomly assigned to either BCAA (n=10) or placebo (n=10) groups. Subjects performed a squatting exercise to elicit DOMS and rated their muscle soreness every 24 hours for four days following exercise while continuing to consume the BCAA or placebo. Following a three-week recovery period, subjects returned and received the alternate BCAA or placebo treatment, repeating the same exercise and DOMS rating protocol for the next four days. BCAA supplementation in female subjects resulted in a significant decrease in DOMS versus placebo at 24 hours following exercise (p = 0.018). No significant effect of BCAA supplementation versus placebo was noted in male subjects, nor when male and female results were analyzed together. This gender difference may be related to dose per body weight differences between male and female subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branch Chain Amino Acid supplement | Experimental | Dietary Supplement: Branched Chain Amino Acid drink supplementA drink supplement containing 1.22 grams of branched chain amino acids, plus glucose. |
| Placebo supplement | Placebo comparator | Dietary Supplement: PlaceboThe placebo was formulated to match both the taste and color of the test supplement. Crystal Light Lemonade powder (Kraft Foods, Northfield, IL, USA) was mixed with 5.6g of powdered dextrose (Now Foods, Bloomingdale, IL, USA) to match the amount of dextrose present in the BCAA supplement. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men (n=9) and women (n=11) aged 18-25 who engaged in no more than one hour of light to moderate intensity physical activity per week were recruited from the Greater Burlington, Vermont area.
Key exclusion criteria (3 listed)
- individuals who engaged in more than one hour per week of light to moderate physical activity
- had been involved in strict athletic competition or weight training in the past six months
- were pregnant or nursing, had a known muscular disease, diabetes mellitus, cardiovascular disease, respiratory disease, and/or were currently taking a protein-based dietary supplement
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 |
|---|---|---|
| Branched Chain Amino Acid drink supplement | Dietary supplement | Branch Chain Amino Acid supplement |
| Placebo | Dietary supplement | Placebo supplement |
Primary outcome
Delayed Onset Muscle Soreness Rating Scale
Time frame: Every 24 hours for four days following exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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. This study is not recruiting at the moment.
Stephen J Pintauro, Ph.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched Chain Amino Acid drink supplement in people with Exercise-induced Delayed Onset Muscle Soreness, run by University of Vermont 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 1 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: finished, as of the sponsor's last update on 1 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Onset Muscle Soreness Rating Scale (time frame: Every 24 hours for four days following exercise). 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 1 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.