Nutritional Intervention for Age-related Muscular Function and Strength Losses

NCT00874575 | Completed Phase 1 DMC

• 1 other identifier: MTI2008-CS01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Keywords

HMB; Vitamin D; Older Adults

Outcome Measures

Primary Outcomes (1)

• Muscular Strength and functionality

  12 weeks

Secondary Outcomes (1)

• Bone turnover

  12 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Control

Dietary Supplement: Placebo

2

EXPERIMENTAL

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

Dietary Supplement: Beta-hydroxy-Beta-methylbutyrate

3

EXPERIMENTAL

Vitamin D, 2000 IU/d

Dietary Supplement: Vitamin D

4

EXPERIMENTAL

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

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

Interventions

Placebo DIETARY_SUPPLEMENT

1

Vitamin D DIETARY_SUPPLEMENT

Also known as: Cholecalciferol

3

Beta-hydroxy-Beta-methylbutyrate DIETARY_SUPPLEMENT

Also known as: HMB

2

Beta-hydroxy-Beta-methylbutyrate and Vitamin D DRUG

Also known as: Beta-hydroxy-Beta-methylbutyrate: HMB, Vitamin D: Cholecalciferol

4

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabolic Technologies Inc.: lead
• Iowa State University: collaborator
• South Dakota State University: collaborator

Study Sites (2)

Iowa State University

Ames, Iowa, 50010, United States

Location

South Dakota State University

Brookings, South Dakota, 57007, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Vitamin D; Cholecalciferol; beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• John A. Rathmacher, Ph.D.

  Metabolic Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: November 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (2)