The Effects of Leucine Metabolites in Performance, Body Composition and Biochemical Markers of Muscle Damage

NCT ID: NCT03511092

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2017-10-28

Brief 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. 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.

Conditions

Resistance Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

HMB-FA

Group Type: EXPERIMENTAL

HMB-FA

Intervention Type: DIETARY_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-Ca

Group Type: EXPERIMENTAL

HMB-Ca

Intervention Type: DIETARY_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-HICA

Group Type: EXPERIMENTAL

alfa-HICA

Intervention Type: DIETARY_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

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: OTHER

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.

Interventions

HMB-FA

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.

Intervention Type: DIETARY_SUPPLEMENT

HMB-Ca

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.

Intervention Type: DIETARY_SUPPLEMENT

alfa-HICA

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparator

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Resistance training subjects for more than one year

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Faculdade de Motricidade Humana

OTHER

Sponsor Role: lead

Responsible Party

Cristina Monteiro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Human Kinetics

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

LabFisiolBioqMLeu

Identifier Type: -

Identifier Source: org_study_id