Nutritional Intervention for Age-Related Muscular Function and Strength Losses - Full Text View

Sponsored by:	Metabolic Technologies Inc.
Information provided by:	Metabolic Technologies Inc.
ClinicalTrials.gov Identifier:	NCT00874575

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 the one of six 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 6) having blood drawn for biochemical measurements. Testing will be performed at the beginning and 4, 8 and 12 weeks.

Condition	Intervention
Muscle Strength Sarcopenia	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
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:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Vitamin D

U.S. FDA Resources

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Control	Dietary Supplement: Placebo Placebo control
2: Experimental Beta-hydroxy-Beta-methylbutyrate, 3 g/d	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Beta-hydroxy-beta-methybutyrate: 0 or 3 g/d for 12 weeks Vitamin D: 0, 500, or 2000 IU/d for 12 weeks
3: Experimental Vitamin D, 500 IU/d	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Beta-hydroxy-beta-methybutyrate: 0 or 3 g/d for 12 weeks Vitamin D: 0, 500, or 2000 IU/d for 12 weeks
4: Experimental Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (500 IU/d)	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Beta-hydroxy-beta-methybutyrate: 0 or 3 g/d for 12 weeks Vitamin D: 0, 500, or 2000 IU/d for 12 weeks
5: Experimental Vitamin D, 2000 IU/d	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Beta-hydroxy-beta-methybutyrate: 0 or 3 g/d for 12 weeks Vitamin D: 0, 500, or 2000 IU/d for 12 weeks
6: Experimental Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d)	Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate and/ or Vitamin D Beta-hydroxy-beta-methybutyrate: 0 or 3 g/d for 12 weeks Vitamin D: 0, 500, or 2000 IU/d for 12 weeks

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion/Exclusion Criteria:

Male and Female
Age > 60 years
Functionality score ('Get-up-and-Go' test) must be > 10.0 sec but < 20.0 sec
Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension and/or diabetes (diet controlled)
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 fat greater than 30% for men and 35% for women)
Six weeks since major surgery (three weeks since minor surgery)
Willing to participate in 3-day a week monitored strength-training program.
Willing to consume one of the nutritional supplements for the study period.
Individuals diagnosed with osteoporosis (i.e., bone density of hip greater than 2.5 standard deviations below the mean) will not be enrolled in the study
Physician has placed no restrictions on physical exercise

Contacts and Locations

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

Contacts

Contact: Matthew Vukovich, Ph.D.

605-688-6580

MATT.VUKOVICH@SDSTATE.EDU

Locations

United States, South Dakota
South Dakota State University	Recruiting
Brookings, South Dakota, United States, 57007
Contact: Matthew Vukovich, Ph.D. 605-688-6580 MATT.VUKOVICH@SDSTATE.EDU
Principal Investigator: Matthew Vukovich, Ph.D.

Sponsors and Collaborators

Metabolic Technologies Inc.

Investigators

Principal Investigator:

John A. Rathmacher, Ph.D.

Metabolic Technologies

More Information

No publications provided

Responsible Party:	Metabolic Technologies ( John A. Rathmacher, Ph.D., Research Scientist )
Study ID Numbers:	MTI2008-CS01
Study First Received:	March 31, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874575 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Metabolic Technologies Inc.:

HMB
Vitamin D
Older Adults

Study placed in the following topic categories:

Vitamin D
Vitamin D2
Asthenia
Ergocalciferol
Vitamins
Ergocalciferols

Beta-hydroxy-beta-methylbutyrate
Trace Elements
Bone Density Conservation Agents
Calciferol
Micronutrients

Additional relevant MeSH terms:

Vitamin D
Growth Substances
Vitamins
Physiological Effects of Drugs

Ergocalciferols
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009