The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Obesity Clinical Trial

Official title:

The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02717013
• Other study ID #: MTI2016-CS01
• Status: Terminated
• Phase: N/A
• First received: March 11, 2016
• Last updated: February 28, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

Dietary Supplement:
• Placebo
Placebo capsules containing calcium lactate similar to the HMB capsules.
• HMB
HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

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