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Nutritional Intervention for Age-related Muscular Function and Strength Losses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874575
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : September 17, 2014
Sponsor:
Collaborators:
Iowa State University
South Dakota State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.

Study Description
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Brief Summary:

The purpose of the study is to

  • Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and functionality in older adults.

The second aim of the study is to determine if HMB and Vitamin D improves markers of bone turnover in adults aged 60 plus years. HMB is a dietary supplement that comes from the amino acid leucine. HMB is found in foods and is made in your body after you eat protein (meat). Subjects will be randomized to one of four dietary supplement groups and will participate in a 3-day per week exercise program for 12 weeks. Each exercise day will be about 60 minutes long consisting of strength training exercises utilizing Theraband® stretch cords and jumping.

Subjects will consume the dietary supplement 2 times per day for 12 weeks. Tests will consist of the following:

  • Measuring the strength of subjects' legs by using a Isokinetic Dynamometer
  • Measuring body composition
  • Measuring hand-grip strength using a hand-grip dynamometer
  • Measuring functional mobility, balance and agility by the time it takes for you to rise from a chair, walk around a cone 8 feet in front of the chair and return to the chair (Up-&-Go Test
  • Filling out questionnaires and having blood drawn for biochemical measurements. Testing will be performed at the beginning and at 4, 8 and 12 weeks.

Condition or disease Intervention/treatment Phase
Muscle Strength Sarcopenia Dietary Supplement: Placebo Dietary Supplement: Vitamin D Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate Drug: Beta-hydroxy-Beta-methylbutyrate and Vitamin D Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults.
Study Start Date : November 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Control
 Dietary Supplement: Placebo
Experimental: 2
Beta-hydroxy-Beta-methylbutyrate, 3 g/d
 Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate
Other Name: HMB
Experimental: 3
Vitamin D, 2000 IU/d
 Dietary Supplement: Vitamin D
Other Name: Cholecalciferol
Experimental: 4
Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d)
 Drug: Beta-hydroxy-Beta-methylbutyrate and Vitamin D
Other Names:
  • Beta-hydroxy-Beta-methylbutyrate: HMB
  • Vitamin D: Cholecalciferol


Outcome Measures
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Primary Outcome Measures :
  1. Muscular Strength and functionality [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Bone turnover [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subjects must meet all of the inclusion criteria in order to participate in the study.

  • Male and Female subjects will be enrolled into the study.
  • Age > 60 years.
  • Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
  • Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
  • Not classified as morbidly obese (body mass index (BMI) >40 kg/m2).
  • Six weeks since major surgery (three weeks since minor surgery).
  • Willing to consume one of the nutritional supplements for the study period.
  • Individuals diagnosed with osteoporosis (i.e., bone density > 2.5 standard deviations below the mean) will not be enrolled in the study.
  • No other serious medical illness.
  • Serum 25OH-VitD3 >10 and <25 ng/ml.
  • Able and willing to participate in 3-day-a-week monitored strength-training program.
  • Physician has placed no restriction on physical exercise.

All candidates meeting any one of the exclusion criteria will not be enrolled into the study and as necessary will be referred to their private physician for further follow-up.

  • Age < 60 years.
  • Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I diabetes mellitus requiring insulin for glucose control.
  • Presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
  • Classified as morbidly obese (body mass index (BMI) >40 kg/m2).
  • Less than six weeks since major surgery or three weeks since minor surgery.
  • Not willing to consume one of the nutritional supplements for the study period.
  • Individuals diagnosed with osteoporosis (i.e., bone density > 2.5 standard deviations below the mean) will not be enrolled in the study.
  • Other serious medical illness, which the subjects doctor or medical review team has decided affects the subject's ability to participate in the study.
  • Subjects on high dose vitamin D therapies (i.e. 50,000 IU vitamin D).
  • Subjects with serum 25OH-VitD3 <10 ng/ml will be considered deficient and will be referred to their physician for treatment.
  • Subjects with serum 25OH-VitD3 >25 ng/ml.
  • Not able or willing to participate in 3-day-a-week monitored strength-training program.
  • Physician has placed a restriction on physical exercise.
Contacts and Locations
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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): NCT00874575


Locations
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United States, Iowa
Iowa State University
Ames, Iowa, United States, 50010
United States, South Dakota
South Dakota State University
Brookings, South Dakota, United States, 57007
Sponsors and Collaborators
Metabolic Technologies Inc.
Iowa State University
South Dakota State University
Investigators
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Principal Investigator: John A. Rathmacher, Ph.D. Metabolic Technologies
More Information
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Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT00874575    
Other Study ID Numbers: MTI2008-CS01
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Metabolic Technologies Inc.:
HMB
Vitamin D
Older Adults
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Vitamin D
 Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents