Nutritional Intervention for Age-related Muscular Function and Strength Losses

Sarcopenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874575
• Other study ID #: MTI2008-CS01
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: September 16, 2014
• Start date: November 2008
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Strength
• Sarcopenia

Intervention

Dietary Supplement:
• Placebo

• Vitamin D

• Beta-hydroxy-Beta-methylbutyrate

Drug:
• Beta-hydroxy-Beta-methylbutyrate and Vitamin D

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa
United States	South Dakota State University	Brookings	South Dakota

Sponsors (3)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	Iowa State University, South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular Strength and functionality		12 weeks	No
Secondary	Bone turnover		12 weeks	No