Clinical trial NCT02717013: The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
Official title: The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Muscle
Bone
Fat
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iowa State University
First posted: 2016-03-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maintenance of bone mineral density
timeFrame: 8 weeks
measure: Maintenance of lean mass
timeFrame: 8 weeks
measure: Maintenance of muscle strength
timeFrame: 8 weeks
measure: Maintenance of hand muscle strength
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Rudy Valentine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References: