Iowa State University
Ames, Iowa, 50010, United States
NCT Number: NCT02043171
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.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Phase 1
Ames, Iowa, 50010, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A Placebo comparator
Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)
Other names: HMB (Calcium beta-hydroxy-beta-methylbutyrate), Vitamin D (Cholecalciferol)
This group will not participate in 3 times per week strength training
This group will participate in a supervised 3 times per week strength training program
Time frame: 12 Months
Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.
Time frame: 12 months
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
Time frame: 12 months
Body composition will be measured by bioelectrical impedance analysis (BIA)and dual-energy X-ray absorptiometry (DXA), and air displacement plethysmography (BODPOD) during the study.
Time frame: 12 months
Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.
Metabolic Technologies Inc.
Industry
Year-long Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D With and Without Exercise on Muscular Strength and Functionality in Older Adults.
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