The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Dietary Supplement: HMB; Dietary Supplement: Placebo

• Registration Number: NCT02717013
• Lead Sponsor: Metabolic Technologies Inc.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMB No Diet Restriction	HMB	-
Placebo Diet Restriction	Placebo	-
HMB Diet Restriction	HMB	-
Placebo No Diet Restriction	Placebo	-

Primary Outcome Measures

Name	Time	Method
Maintenance of bone mineral density	8 weeks	Bone mineral density measured by DXA (T-score)
Maintenance of lean mass	8 weeks	Lean Mass measured by DXA (kg)
Maintenance of muscle strength	8 weeks	Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)
Maintenance of hand muscle strength	8 weeks	Hand muscle strength will be assessed using hand grips (kg)

Trial Locations

Locations (1)

Iowa State University; 🇺🇸 Ames, Iowa, United States