The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Study Overview
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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.

Official Title
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The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: HMB


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Diet Restriction<br> | Dietary Supplement: Placebo<br>* Placebo capsules containing calcium lactate similar to the HMB capsules.<br>|
| Placebo Comparator: Placebo No Diet Restriction<br> | Dietary Supplement: Placebo<br>* Placebo capsules containing calcium lactate similar to the HMB capsules.<br>|
| Active Comparator: HMB Diet Restriction<br> | Dietary Supplement: HMB<br>* HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.<br>|
| Active Comparator: HMB No Diet Restriction<br> | Dietary Supplement: HMB<br>* HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat, Muscle, Bone