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The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

Primary Purpose

Obesity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

HMB

About this trial

This is an interventional basic science trial for Obesity focused on measuring Muscle, Bone, Fat

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

Iowa State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Diet Restriction

Placebo No Diet Restriction

HMB Diet Restriction

HMB No Diet Restriction

Arm Description

Outcomes

Primary Outcome Measures

Maintenance of bone mineral density

Bone mineral density measured by DXA (T-score)

Maintenance of lean mass

Lean Mass measured by DXA (kg)

Maintenance of muscle strength

Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)

Maintenance of hand muscle strength

Hand muscle strength will be assessed using hand grips (kg)

Secondary Outcome Measures

Full Information

NCT ID

NCT02717013

First Posted

March 11, 2016

Last Updated

February 28, 2017

Sponsor

Metabolic Technologies Inc.

Collaborators

Iowa State University

1. Study Identification

Unique Protocol Identification Number

NCT02717013

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of recruitment of subjects.

Study Start Date

March 2016 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Metabolic Technologies Inc.

Collaborators

Iowa State University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Muscle, Bone, Fat

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Diet Restriction

Arm Type

Placebo Comparator

Arm Title

Placebo No Diet Restriction

Arm Type

Placebo Comparator

Arm Title

HMB Diet Restriction

Arm Type

Active Comparator

Arm Title

HMB No Diet Restriction

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules containing calcium lactate similar to the HMB capsules.

Intervention Type

Dietary Supplement

Intervention Name(s)

HMB

Intervention Description

HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.

Primary Outcome Measure Information:

Title

Maintenance of bone mineral density

Description

Bone mineral density measured by DXA (T-score)

Time Frame

8 weeks

Title

Maintenance of lean mass

Description

Lean Mass measured by DXA (kg)

Time Frame

8 weeks

Title

Maintenance of muscle strength

Description

Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)

Time Frame

8 weeks

Title

Maintenance of hand muscle strength

Description

Hand muscle strength will be assessed using hand grips (kg)

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudy Valentine, PhD

Organizational Affiliation

Iowa State University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John A Rathmacher, PhD

Organizational Affiliation

Metabolic Technologies Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Iowa State University

City

Ames

State/Province

Iowa

ZIP/Postal Code

50011

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No Individual Data will be shared. Data summaries will be available after publication..

Learn more about this trial

The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

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