NCT02043171

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Metabolic Technologies Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

• Sarcopenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2014-01-23
• Last updated: 2019-02-11

Locations

1 site across 1 country: United States