Muscle DamageNCT01793779
Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness
A study testing cold water immersion and beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) in people with Muscle Damage, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
Study Objectives 1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise. 2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion. 3. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- cold water immersion and beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one-year of resistance training experience
- Free of any physical limitations (determined by health and activity questionnaire).
- Between the ages of 18 and 35
Who cannot join
- Inability to perform physical exercise (determined by health and activity questionnaire)
- Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
- Any chronic illness that causes continuous medical care
- Taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida, Sport and Exercise Science
Orlando, Florida, 32816
About this study
Official title: Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness in Experienced Resistance Trained Individuals.
Study Objectives
- Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise.
- Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.
- Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function.
Read more
Subjects
Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. Subjects will be randomly divided into one of four groups: a cold water immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).
Study Protocol
Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each workout and CW+HMB-FA will be administered together at time points describe above.
Statistical Analysis
Statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (ANOVA).
- Conditions
- Muscle Damage
- Being tested
- cold water immersion, beta-hydroxy-beta-methylbutyrate free acid (HMB-FA), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold water immersionProcedure or surgery
beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo supplement given prior to exercise and two times per day following exercise Receives: Dietary Supplement: Placebo |
| cold water immersion | Experimental | Placebo supplement to be give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise Receives: Procedure: cold water immersion; Dietary Supplement: Placebo |
| HMB-FA | Experimental | beta-hydroxy-beta-methylbutyrate free acid supplement to be give prior to exercise and two times per day following exercise Receives: Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) |
| cold water immersion group + HMB-FA | Experimental | beta-hydroxy-beta-methylbutyrate free acid supplement give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise Receives: Procedure: cold water immersion; Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal muscle strength
The 1-RM tests will be performed to assess maximal muscle strength.
Measured: Change from baseline over 48 hours post-exercise.
Secondary outcomes (1)
Muscle damage
Serum creatine kinase and myoglobin concentrations will be analyzed as markers of muscle damage.
Measured: Change from baseline over 48 hours post-exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793779
- Sponsor's protocol ID
- MTI2013-CS01
- Status last verified
- Jul 2013
- First submitted
- 13 Feb 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ascensao A, Leite M, Rebelo AN, Magalhaes S, Magalhaes J. Effects of cold water immersion on the recovery of physical performance and muscle damage following a one-off soccer match. J Sports Sci. 2011 Feb;29(3):217-25. doi: 10.1080/02640414.2010.526132.
PubMed 21170794Fuller JC Jr, Sharp RL, Angus HF, Baier SM, Rathmacher JA. Free acid gel form of beta-hydroxy-beta-methylbutyrate (HMB) improves HMB clearance from plasma in human subjects compared with the calcium HMB salt. Br J Nutr. 2011 Feb;105(3):367-72. doi: 10.1017/S0007114510003582. Epub 2010 Dec 7.
PubMed 21134325
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness in Experienced Resistance Trained Individuals.
- ClinicalTrials.gov ID
- NCT01793779
- Acronym / sponsor ID
- MTI2013-CS01
- Conditions
- Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 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.
Study Objectives
- Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise.
- Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion.
- Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function.
Subjects
Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. Subjects will be randomly divided into one of four groups: a cold water immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT).
Study Protocol
Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On the first visit (T1) subjects will be tested for maximal strength [one repetition-maximum (1-RM)] on the squat, dead lift and barbell lunge exercises.] On their second visit (T2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each workout and CW+HMB-FA will be administered together at time points describe above.
Statistical Analysis
Statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (ANOVA).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplement given prior to exercise and two times per day following exercise |
| cold water immersion | Experimental | Procedure: cold water immersion, Dietary Supplement: PlaceboPlacebo supplement to be give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise |
| HMB-FA | Experimental | Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)beta-hydroxy-beta-methylbutyrate free acid supplement to be give prior to exercise and two times per day following exercise |
| cold water immersion group + HMB-FA | Experimental | Procedure: cold water immersion, Dietary Supplement: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)beta-hydroxy-beta-methylbutyrate free acid supplement give prior to exercise and two times per day following exercise in combination with cold water immersion therapy following exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least one-year of resistance training experience
- Free of any physical limitations (determined by health and activity questionnaire).
- Between the ages of 18 and 35
Key exclusion criteria (4 listed)
- Inability to perform physical exercise (determined by health and activity questionnaire)
- Taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire).
- Any chronic illness that causes continuous medical care
- Taking any type of prescription or over-the-counter medication, having any chronic illness causing you to seek medical care, pregnancy
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 |
|---|---|---|
| cold water immersion | Procedure or surgery | cold water immersion, cold water immersion group + HMB-FA |
| beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) | Dietary supplement | HMB-FA, cold water immersion group + HMB-FA |
| Placebo | Dietary supplement | Control, cold water immersion |
Primary outcome
Maximal muscle strength
Time frame: Change from baseline over 48 hours post-exercise.
The 1-RM tests will be performed to assess maximal muscle strength.
1 secondary outcome
Muscle damage
Time frame: Change from baseline over 48 hours post-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 Aug 2013.
- Background: PubMed 21170794Ascensao A, Leite M, Rebelo AN, Magalhaes S, Magalhaes J. Effects of cold water immersion on the recovery of physical performance and muscle damage following a one-off soccer match. J Sports Sci. 2011 Feb;29(3):217-25. doi: 10.1080/02640414.2010.526132.
- Background: PubMed 21134325Fuller JC Jr, Sharp RL, Angus HF, Baier SM, Rathmacher JA. Free acid gel form of beta-hydroxy-beta-methylbutyrate (HMB) improves HMB clearance from plasma in human subjects compared with the calcium HMB salt. Br J Nutr. 2011 Feb;105(3):367-72. doi: 10.1017/S0007114510003582. Epub 2010 Dec 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold water immersion and beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) in people with Muscle Damage, run by Metabolic Technologies Inc. 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 4 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 Aug 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?
Maximal muscle strength (time frame: Change from baseline over 48 hours post-exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793779, which also lists 2 linked publications.
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 Aug 2013.