Nutritional Intervention for Age-related Muscular Function and Strength Losses

This study has been completed.
Sponsor:
Collaborators:
Iowa State University
South Dakota State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00874575
First received: March 31, 2009
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Metabolic Technologies Inc.:

Primary Outcome Measures:
  • Muscular Strength and functionality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone turnover [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: November 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874575

Locations
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
Principal Investigator: John A. Rathmacher, Ph.D. Metabolic Technologies
  More Information

No publications provided

Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT00874575     History of Changes
Other Study ID Numbers: MTI2008-CS01
Study First Received: March 31, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Metabolic Technologies Inc.:
HMB
Vitamin D
Older Adults

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014