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Nutritional Intervention for Age-related Muscular Function and Strength Losses

Primary Purpose

Muscle Strength, Sarcopenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

Vitamin D

Beta-hydroxy-Beta-methylbutyrate

Beta-hydroxy-Beta-methylbutyrate and Vitamin D

About this trial

This is an interventional treatment trial for Muscle Strength focused on measuring HMB, Vitamin D, Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Iowa State University
South Dakota State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Control

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

Vitamin D, 2000 IU/d

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

Outcomes

Primary Outcome Measures

Muscular Strength and functionality

Secondary Outcome Measures

Bone turnover

Full Information

NCT ID

NCT00874575

First Posted

March 31, 2009

Last Updated

September 16, 2014

Sponsor

Metabolic Technologies Inc.

Collaborators

Iowa State University, South Dakota State University

1. Study Identification

Unique Protocol Identification Number

NCT00874575

Brief Title

Nutritional Intervention for Age-related Muscular Function and Strength Losses

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Metabolic Technologies Inc.

Collaborators

Iowa State University, South Dakota State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Strength, Sarcopenia

Keywords

HMB, Vitamin D, Older Adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Control

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Vitamin D, 2000 IU/d

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Cholecalciferol

Intervention Type

Dietary Supplement

Intervention Name(s)

Beta-hydroxy-Beta-methylbutyrate

Other Intervention Name(s)

HMB

Intervention Type

Drug

Intervention Name(s)

Beta-hydroxy-Beta-methylbutyrate and Vitamin D

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Muscular Strength and functionality

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Bone turnover

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John A. Rathmacher, Ph.D.

Organizational Affiliation

Metabolic Technologies

Official's Role

Principal Investigator

Facility Information:

Facility Name

Iowa State University

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010

Country

United States

Facility Name

South Dakota State University

City

Brookings

State/Province

South Dakota

ZIP/Postal Code

57007

Country

United States

12. IPD Sharing Statement

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Nutritional Intervention for Age-related Muscular Function and Strength Losses

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