The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: HMB

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ames, Iowa, United States, 50011
      • Iowa State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Metabolic Technologies Inc.
• Collaborators: Iowa State University
• Investigators: Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.; Principal Investigator: Rudy Valentine, PhD, Iowa State University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Bone; Fat; Muscle
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: MTI2016-CS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No Individual Data will be shared. Data summaries will be available after publication..