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Clinical Trials/NCT03511092
NCT03511092CompletedNot Applicable

The Effects of β-hydroxy-β-methylbutyrate and Leucic Acid in Performance, Body Composition and Biochemical Markers

Faculdade de Motricidade Humana1 site in 1 country53 target enrollmentStarted: May 29, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Change of body water

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.
  • •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

Arms & Interventions

HMB-FA

Experimental

Intervention: HMB-FA (Dietary Supplement)

HMB-Ca

Experimental

Intervention: HMB-Ca (Dietary Supplement)

alfa-HICA

Experimental

Intervention: alfa-HICA (Dietary Supplement)

Placebo

Placebo Comparator

Intervention: Placebo comparator (Other)

Outcomes

Primary Outcomes

Change of body water

Time Frame: Baseline, week 4 and week 8

kg

Change of peak power

Time Frame: Baseline, week 4 and week 8

Watt

Change of maximum strength

Time Frame: Baseline, week 4 and week 8

kg

Change of jump height

Time Frame: Baseline, week 4 and week 8

cm

Change of muscle thickness

Time Frame: Baseline, week 4 and week 8

mm

Change of fat mass

Time Frame: Baseline, week 4 and week 8

Change of power

Time Frame: Baseline, week 4 and week 8

Watt

Change of fat free mass

Time Frame: Baseline, week 4 and week 8

kg

Secondary Outcomes

  • Heart rate(Baseline and week 8)
  • Change of biochemical markers of muscle damage(Baseline, week 4 and week 8)
  • Oxygen uptake(Baseline and week 8)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cristina Monteiro

Assistant Professor

Faculdade de Motricidade Humana

Study Sites (1)

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