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The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

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ClinicalTrials.gov Identifier: NCT02717013
Recruitment Status : Terminated (Lack of recruitment of subjects.)
First Posted : March 23, 2016
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Iowa State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Placebo Dietary Supplement: HMB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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.




Primary Outcome Measures :
  1. Maintenance of bone mineral density [ Time Frame: 8 weeks ]
    Bone mineral density measured by DXA (T-score)

  2. Maintenance of lean mass [ Time Frame: 8 weeks ]
    Lean Mass measured by DXA (kg)

  3. Maintenance of muscle strength [ Time Frame: 8 weeks ]
    Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)

  4. Maintenance of hand muscle strength [ Time Frame: 8 weeks ]
    Hand muscle strength will be assessed using hand grips (kg)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717013


Locations
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United States, Iowa
Iowa State University
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Metabolic Technologies Inc.
Iowa State University
Investigators
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Principal Investigator: Rudy Valentine, PhD Iowa State University
Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
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Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT02717013    
Other Study ID Numbers: MTI2016-CS01
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Individual Data will be shared. Data summaries will be available after publication..
Keywords provided by Metabolic Technologies Inc.:
Muscle
Bone
Fat
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes