The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Metabolic Technologies

Status: Terminated

Conditions: Obesity

Treatments: Dietary Supplement: HMB; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02717013

MTI2016-CS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 4 patient groups, including a placebo group

Placebo Diet Restriction

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Placebo No Diet Restriction

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

HMB Diet Restriction

Active Comparator group

Treatment:

Dietary Supplement: HMB

HMB No Diet Restriction

Active Comparator group

Treatment:

Dietary Supplement: HMB