Nutritional Intervention for Age-related Muscular Function and Strength Losses

NCT ID: NCT00874575

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-07-31

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.

Conditions

Muscle Strength; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2

Beta-hydroxy-Beta-methylbutyrate, 3 g/d

Group Type: EXPERIMENTAL

Beta-hydroxy-Beta-methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

3

Vitamin D, 2000 IU/d

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

4

Beta-hydroxy-Beta-methylbutyrate (3 g/d) + Vitamin D (2000 IU/d)

Group Type: EXPERIMENTAL

Beta-hydroxy-Beta-methylbutyrate and Vitamin D

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxy-Beta-methylbutyrate

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxy-Beta-methylbutyrate and Vitamin D

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol; HMB; Beta-hydroxy-Beta-methylbutyrate: HMB; Vitamin D: Cholecalciferol

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iowa State University

OTHER

Sponsor Role: collaborator

South Dakota State University

OTHER

Sponsor Role: collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A. Rathmacher, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Metabolic Technologies

Locations

Iowa State University

Ames, Iowa, United States

South Dakota State University

Brookings, South Dakota, United States

Countries

United States

Other Identifiers

MTI2008-CS01

Identifier Type: -

Identifier Source: org_study_id