NCT02717013

Brief Summary

This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

March 11, 2016

Last Update Submit

February 28, 2017

Conditions

Obesity

Keywords

MuscleBoneFat

Outcome Measures

Primary Outcomes (4)

  • Maintenance of bone mineral density

    Bone mineral density measured by DXA (T-score)

    8 weeks

  • Maintenance of lean mass

    Lean Mass measured by DXA (kg)

    8 weeks

  • Maintenance of muscle strength

    Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)

    8 weeks

  • Maintenance of hand muscle strength

    Hand muscle strength will be assessed using hand grips (kg)

    8 weeks

Study Arms (4)

Placebo Diet Restriction

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Placebo No Diet Restriction

PLACEBO COMPARATOR
Dietary Supplement: Placebo

HMB Diet Restriction

ACTIVE COMPARATOR
Dietary Supplement: HMB

HMB No Diet Restriction

ACTIVE COMPARATOR
Dietary Supplement: HMB

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo capsules containing calcium lactate similar to the HMB capsules.

Placebo Diet RestrictionPlacebo No Diet Restriction
HMBDIETARY_SUPPLEMENT

HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.

HMB Diet RestrictionHMB No Diet Restriction

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Non-smoker
  • Body mass index of 35-40 kg/m2
  • Age 18-40 years
  • Weight stable for past 6 months (\<5 lb. change)
  • In good health, free of chronic diseases/conditions that may impact measured outcomes
  • Willing and able to consume a weight loss diet
  • Willing and able to consume a daily nutritional supplement (in pill form)
  • Available for scheduled study commitments during the 2 months of study

You may not qualify if:

  • Smoke
  • Take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition
  • Weigh greater 300 pounds due to weight, size and depth limitations of equipment
  • Take dietary supplements
  • Have a chronic disease such as:
  • Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease
  • Severe orthopedic/musculoskeletal or neuromuscular impairments that would contradict exercise
  • Sensory impairments that interfere with following directions
  • Diagnosis if dementia
  • History of malignancy during the past 5 years
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

ObesityPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rudy Valentine, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

  • John A Rathmacher, PhD

    Metabolic Technologies Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 23, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No Individual Data will be shared. Data summaries will be available after publication..

Locations

US(1)