A Phase 1 interventional study of Placebo and HMB plus Vitamin D in Sarcopenia, sponsored by Metabolic Technologies Inc.. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Metabolic Technologies Inc. · Phase 1, Interventional, and Treatment
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.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 238 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Metabolic Technologies Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Placebo supplementation group with 3 days per week of exercise
Dietary Supplement: Placebo · Behavioral: Exercise
Placebo supplementation group without exercise
Dietary Supplement: Placebo · Behavioral: Non-Exercise
HMB plus Vitamin D supplementation group with 3 days per week of exercise
Drug: HMB plus Vitamin D · Behavioral: Exercise
HMB plus Vitamin D supplementation group without exercise
Drug: HMB plus Vitamin D · Behavioral: Non-Exercise
A Placebo comparator
Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)
Also known as: 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
Muscular strength
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
Functionality
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
Time frame: 12 months
Muscle mass
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
Quality of life
Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.
Time frame: 12 months
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Metabolic Technologies Inc.