Resistance TrainingLMET2IMPROVENCT03511092
The Effects of Leucine Metabolites in Performance, Body Composition and Biochemical Markers of Muscle Damage
A study testing HMB-FA, HMB-Ca and alfa-HICA in people with Resistance Training, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
This study aimed to conduct a double-blind randomized pragmatic trial to evaluate the effects of off-the-shelf leucine metabolite supplements HMB-FA, HMB-Ca, alfa-HICA, on resistance training-induced changes in body composition, performance and biochemical markers of muscle damage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training
- What is being tested?
- HMB-FA, HMB-Ca and alfa-HICA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- 29 May 2017to 28 Oct 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resistance training subjects for more than one year
Who cannot join
- Individuals taking any type of drug, medicines or supplements that may enhance body composition or performance, 1 months prior to the research.
- Smokers
- Clinical diagnose of a disease that might compromise tolerance to the supplements or influence body composition and performance
- More than 25% body fat
- Individuals involved in similar research 3 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of β-hydroxy-β-methylbutyrate and Leucic Acid in Performance, Body Composition and Biochemical Markers
This study aimed to conduct a double-blind randomized pragmatic trial to evaluate the effects of off-the-shelf leucine metabolite supplements HMB-FA, HMB-Ca, alfa-HICA, on resistance training-induced changes in body composition, performance and biochemical markers of muscle damage. The investigators' working hypothesis is that so long as subjects adhered to a diet containing adequate energy and dietary protein, there would be no differences between those receiving the leucine metabolites - HMB-FA, HMB-Ca and alfa-HICA - when compared to a placebo consuming group.
Read the detailed description
This was a randomized, double blind, placebo-controlled study with additional control of diet. The investigators compared the effect of 8 weeks of supplementation with HMB-FA, HMB-Ca, or alfa-HICA on performance, body composition, and biochemical markers of muscle damage. The study involved fifty-three participants engaged in resistance training for at least one year (≥3 training sessions per week).
Performance measures - To evaluate aerobic performance an incremental test to volitional exhaustion was performed. Peak power and strength was assessed by maximum strength and the participants also performed a Wingate and vertical jump tests. Perceived performance and recovery was measured by the perceived recovery status scores in training days. This tool allowed to evaluate both fatigue, general muscle soreness, sleep quality, stress levels and mood throughout the study. Performance tests were performed at baseline, prior to the beginning of the study, and at the end of weeks 4 and 8, in a fed state (a meal replacement bar was provided to participants before the tests).
Body composition measures - To evaluate body composition a dual-energy X-ray absorptiometry (DXA) scan was performed; Muscle thickness was measured by ultrasonography; Total body water and both the extracellular water and intracellular water were assessed by bioelectrical impedance spectroscopy (BIS). These tests were performed at baseline and at the end of weeks 4 and 8, with participants reporting to the lab in a fasted state, refraining from exercise, alcohol or stimulant beverages for at least 8 h.
Biochemical markers of muscle damage - To assess biochemical markers (total testosterone and cortisol, creatine kinase, insulin-like growth factor 1, growth hormone), blood was collected at baseline and at the end of weeks 4 and 8, in a fasted state with participants also refraining from exercise, alcohol or stimulant beverages for at least 12 h.
Training protocol - The training program was designed according to the guidelines for hypertrophy type of resistance training for intermediate-trained individuals and consisted on 3 sessions per week during an 8-week period.
Statistics - sample size was calculated through an a priori power analysis (G*Power Version 3.1.9.2, Heinrich Heine Universitat Dusseldorf, Germany), based on FFM changes from previous studies and power of 0.80. Statistical analysis will be performed using IBM SPSS statistics version 22.0 (IBM, Chicago, Illinois, USA). Normality of the distribution of variables will be tested by Shapiro-Wilk test. Baseline characteristics between groups were analyzed by a 1-way analysis of variance (ANOVA) since normality was observed. Time and time x group interactions will be evaluated by repeated-measures ANOVA. The equality of the matrix of variance and sphericity will be explored with the Levene F test and Mauchly's test, respectively. Overall significance level for α was set at p ≤ 0.05.
- Conditions
- Resistance Training
- Being tested
- HMB-FA, HMB-Ca, alfa-HICA, Placebo comparator
- Keywords
- Leucine metabolites, Resistance training, Hypertrophy, Strength, Supplement
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB-FADietary supplement
One gram of HMB-FA was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks.
HMB-CaDietary supplement
One gram of HMB-Ca was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks.
alfa-HICADietary supplement
Five hundred miligram of alfa-HICA was ingested before exercise, and one gram was ingested at subsequent meals (500 mg per meal). At rest days supplement was administered 500 mg per meal. The total duration of the intervention was 8 weeks.
Placebo comparatorOther
One gram of magnesium stearate was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days placebo was administered 1 g per meal. The total duration of the intervention was 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HMB-FA | Experimental | Not described Receives: Dietary Supplement: HMB-FA |
| HMB-Ca | Experimental | Not described Receives: Dietary Supplement: HMB-Ca |
| alfa-HICA | Experimental | Not described Receives: Dietary Supplement: alfa-HICA |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximum strength
kg
Measured: Baseline, week 4 and week 8
Change of peak power
Watt
Measured: Baseline, week 4 and week 8
Change of jump height
cm
Measured: Baseline, week 4 and week 8
Change of power
Watt
Measured: Baseline, week 4 and week 8
Change of muscle thickness
mm
Measured: Baseline, week 4 and week 8
Change of fat free mass
kg
Measured: Baseline, week 4 and week 8
Change of fat mass
Measured: Baseline, week 4 and week 8
Change of body water
kg
Measured: Baseline, week 4 and week 8
Secondary outcomes (3)
Change of biochemical markers of muscle damage
total testosterone and cortisol, creatine kinase, insulin-like growth factor 1, growth hormone
Measured: Baseline, week 4 and week 8
Oxygen uptake
mL.kg-1.min-1
Measured: Baseline and week 8
Heart rate
beats.min-1
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start29 May 2017
- Primary completion28 Oct 2017
- Study completion28 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Monteiro, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511092
- Sponsor's protocol ID
- LabFisiolBioqMLeu
- Acronym
- LMET2IMPROVE
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2018
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of β-hydroxy-β-methylbutyrate and Leucic Acid in Performance, Body Composition and Biochemical Markers
- ClinicalTrials.gov ID
- NCT03511092
- Acronym / sponsor ID
- LMET2IMPROVE / LabFisiolBioqMLeu
- Conditions
- Resistance Training
- Keywords
- Leucine metabolites, Resistance training, Hypertrophy, Strength, Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 28 Oct 2017 (actual)
- Study completion
- 28 Oct 2017 (actual)
- First posted
- 27 Apr 2018 (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.
This study aimed to conduct a double-blind randomized pragmatic trial to evaluate the effects of off-the-shelf leucine metabolite supplements HMB-FA, HMB-Ca, alfa-HICA, on resistance training-induced changes in body composition, performance and biochemical markers of muscle damage. The investigators' working hypothesis is that so long as subjects adhered to a diet containing adequate energy and dietary protein, there would be no differences between those receiving the leucine metabolites - HMB-FA, HMB-Ca and alfa-HICA - when compared to a placebo consuming group.
Detailed description
This was a randomized, double blind, placebo-controlled study with additional control of diet. The investigators compared the effect of 8 weeks of supplementation with HMB-FA, HMB-Ca, or alfa-HICA on performance, body composition, and biochemical markers of muscle damage. The study involved fifty-three participants engaged in resistance training for at least one year (≥3 training sessions per week).
Performance measures - To evaluate aerobic performance an incremental test to volitional exhaustion was performed. Peak power and strength was assessed by maximum strength and the participants also performed a Wingate and vertical jump tests. Perceived performance and recovery was measured by the perceived recovery status scores in training days. This tool allowed to evaluate both fatigue, general muscle soreness, sleep quality, stress levels and mood throughout the study. Performance tests were performed at baseline, prior to the beginning of the study, and at the end of weeks 4 and 8, in a fed state (a meal replacement bar was provided to participants before the tests).
Body composition measures - To evaluate body composition a dual-energy X-ray absorptiometry (DXA) scan was performed; Muscle thickness was measured by ultrasonography; Total body water and both the extracellular water and intracellular water were assessed by bioelectrical impedance spectroscopy (BIS). These tests were performed at baseline and at the end of weeks 4 and 8, with participants reporting to the lab in a fasted state, refraining from exercise, alcohol or stimulant beverages for at least 8 h.
Biochemical markers of muscle damage - To assess biochemical markers (total testosterone and cortisol, creatine kinase, insulin-like growth factor 1, growth hormone), blood was collected at baseline and at the end of weeks 4 and 8, in a fasted state with participants also refraining from exercise, alcohol or stimulant beverages for at least 12 h.
Training protocol - The training program was designed according to the guidelines for hypertrophy type of resistance training for intermediate-trained individuals and consisted on 3 sessions per week during an 8-week period.
Statistics - sample size was calculated through an a priori power analysis (G*Power Version 3.1.9.2, Heinrich Heine Universitat Dusseldorf, Germany), based on FFM changes from previous studies and power of 0.80. Statistical analysis will be performed using IBM SPSS statistics version 22.0 (IBM, Chicago, Illinois, USA). Normality of the distribution of variables will be tested by Shapiro-Wilk test. Baseline characteristics between groups were analyzed by a 1-way analysis of variance (ANOVA) since normality was observed. Time and time x group interactions will be evaluated by repeated-measures ANOVA. The equality of the matrix of variance and sphericity will be explored with the Levene F test and Mauchly's test, respectively. Overall significance level for α was set at p ≤ 0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HMB-FA | Experimental | Dietary Supplement: HMB-FA |
| HMB-Ca | Experimental | Dietary Supplement: HMB-Ca |
| alfa-HICA | Experimental | Dietary Supplement: alfa-HICA |
| Placebo | Placebo comparator | Other: Placebo comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Resistance training subjects for more than one year
Key exclusion criteria (5 listed)
- Individuals taking any type of drug, medicines or supplements that may enhance body composition or performance, 1 months prior to the research.
- Smokers
- Clinical diagnose of a disease that might compromise tolerance to the supplements or influence body composition and performance
- More than 25% body fat
- Individuals involved in similar research 3 months prior to the study
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 |
|---|---|---|
| HMB-FAOne gram of HMB-FA was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks. | Dietary supplement | HMB-FA |
| HMB-CaOne gram of HMB-Ca was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks. | Dietary supplement | HMB-Ca |
| alfa-HICAFive hundred miligram of alfa-HICA was ingested before exercise, and one gram was ingested at subsequent meals (500 mg per meal). At rest days supplement was administered 500 mg per meal. The total duration of the intervention was 8 weeks. | Dietary supplement | alfa-HICA |
| Placebo comparatorOne gram of magnesium stearate was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days placebo was administered 1 g per meal. The total duration of the intervention was 8 weeks. | Other | Placebo |
Primary outcome
Change of maximum strength
Time frame: Baseline, week 4 and week 8
kg
Change of peak power
Time frame: Baseline, week 4 and week 8
Watt
Change of jump height
Time frame: Baseline, week 4 and week 8
cm
Change of power
Time frame: Baseline, week 4 and week 8
Watt
Change of muscle thickness
Time frame: Baseline, week 4 and week 8
mm
Change of fat free mass
Time frame: Baseline, week 4 and week 8
kg
Change of fat mass
Time frame: Baseline, week 4 and week 8
Change of body water
Time frame: Baseline, week 4 and week 8
kg
3 secondary outcomes
Change of biochemical markers of muscle damage
Time frame: Baseline, week 4 and week 8
Oxygen uptake
Time frame: Baseline and week 8
Heart rate
Time frame: Baseline and week 8
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 22 Feb 2024.
- Individual participant dataSharing planned: No
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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 HMB-FA, HMB-Ca and alfa-HICA in people with Resistance Training, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 5 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 22 Feb 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 Portugal. 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?
Change of maximum strength (time frame: Baseline, week 4 and week 8). The study lists 8 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 Feb 2024.