The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

NCT ID: NCT02717013

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Diet Restriction

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules containing calcium lactate similar to the HMB capsules.

Placebo No Diet Restriction

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules containing calcium lactate similar to the HMB capsules.

HMB Diet Restriction

Group Type ACTIVE_COMPARATOR

HMB

Intervention Type DIETARY_SUPPLEMENT

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

HMB No Diet Restriction

Group Type ACTIVE_COMPARATOR

HMB

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

Placebo capsules containing calcium lactate similar to the HMB capsules.

Intervention Type DIETARY_SUPPLEMENT

HMB

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Iowa State University

OTHER

Sponsor Role collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudy Valentine, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

John A Rathmacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies Inc.

Locations

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Iowa State University

Ames, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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MTI2016-CS01

Identifier Type: -

Identifier Source: org_study_id

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