NCT03511092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

April 2, 2018

Last Update Submit

February 21, 2024

Conditions

Resistance Training

Keywords

Leucine metabolitesResistance trainingHypertrophyStrengthSupplement

Outcome Measures

Primary Outcomes (8)

  • Change of maximum strength

    kg

    Baseline, week 4 and week 8

  • Change of peak power

    Watt

    Baseline, week 4 and week 8

  • Change of jump height

    cm

    Baseline, week 4 and week 8

  • Change of power

    Watt

    Baseline, week 4 and week 8

  • Change of muscle thickness

    mm

    Baseline, week 4 and week 8

  • Change of fat free mass

    kg

    Baseline, week 4 and week 8

  • Change of fat mass

    Baseline, week 4 and week 8

  • Change of body water

    kg

    Baseline, week 4 and week 8

Secondary Outcomes (3)

  • Change of biochemical markers of muscle damage

    Baseline, week 4 and week 8

  • Oxygen uptake

    Baseline and week 8

  • Heart rate

    Baseline and week 8

Study Arms (4)

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

Interventions

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-FA
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.

HMB-Ca
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.

alfa-HICA
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.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Resistance training subjects for more than one year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Kinetics

Lisbon, 1495-002 Cruz-Quebrada, Portugal

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 27, 2018

Study Start

May 29, 2017

Primary Completion

October 28, 2017

Study Completion

October 28, 2017

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)