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

NCT02043171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2019-02-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

A Placebo comparator

DRUG

HMB plus Vitamin D

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

BEHAVIORAL

Non-Exercise

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

BEHAVIORAL

Exercise

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

Sponsors & Collaborators

  • Iowa State University

    collaborator OTHER

  • Metabolic Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • John A Rathmacher, PhD · Metabolic Technologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-02-04
Completion
2019-02-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02043171 on ClinicalTrials.gov