Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-02-04

Brief Summary

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Men and women lose muscle mass and strength with age. Loss of muscle mass and strength is accompanied by a loss of muscle function which can lead to diminished quality of life and more importantly can lead to serious fall requiring medical treatment. The investigators hypothesize that the combined supplements of Calcium-HMB and Vitamin D will lead to decreased falls and to improved quality of life (QOL) for older adults. The investigators further hypothesize that the addition of a modest exercise regimen to these supplements will enhance the synergistic effects of both Calcium-HMB and Vitamin D.

Subjects will consume the dietary supplement 2 times per day for 12 months. Tests will consist of the following: a) strength of subjects' legs and elbow by Isokinetic Dynamometer; b) body composition; c) hand-grip strength by hand-grip dynamometer; d) functional mobility, balance and agility (Get-Up and Get-Up-and-Go tests); e) filling out questionnaires; and g) having blood drawn for biochemical measurements. Testing will be performed at the baseline (0 months) and at 3, 6, 9, and 12 months.

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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Exercise

Placebo supplementation group with 3 days per week of exercise

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A Placebo comparator

Exercise

Intervention Type BEHAVIORAL

This group will participate in a supervised 3 times per week strength training program

Placebo Non-exercise

Placebo supplementation group without exercise

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A Placebo comparator

Non-Exercise

Intervention Type BEHAVIORAL

This group will not participate in 3 times per week strength training

HMB plus Vitamin D Exercise

HMB plus Vitamin D supplementation group with 3 days per week of exercise

Group Type ACTIVE_COMPARATOR

HMB plus Vitamin D

Intervention Type DRUG

Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)

Exercise

Intervention Type BEHAVIORAL

This group will participate in a supervised 3 times per week strength training program

HMB plus Vitamin D Non-exercise

HMB plus Vitamin D supplementation group without exercise

Group Type ACTIVE_COMPARATOR

HMB plus Vitamin D

Intervention Type DRUG

Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)

Non-Exercise

Intervention Type BEHAVIORAL

This group will not participate in 3 times per week strength training

Interventions

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Placebo

A Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

HMB plus Vitamin D

Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)

Intervention Type DRUG

Non-Exercise

This group will not participate in 3 times per week strength training

Intervention Type BEHAVIORAL

Exercise

This group will participate in a supervised 3 times per week strength training program

Intervention Type BEHAVIORAL

Other Intervention Names

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HMB (Calcium beta-hydroxy-beta-methylbutyrate) Vitamin D (Cholecalciferol)

Eligibility Criteria

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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, or bone density \> 2.0 standard deviations below the mean, will not be enrolled in the study.
* No other serious medical illness.
* Serum 25OH-vitD3 \>15 ng/ml.
* 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, or a bone density \> 2.0 standard deviations below the mean, will not be enrolled in the study.
* Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study.
* History of blood clots and/or the use of blood thinning medications
* 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 \>30 ng/ml may not respond to the intervention as expected and will also be excluded from the study.
* 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