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.

Metabolic Technologies Inc.1 site in 1 country238 target enrollmentAugust 2014

ConditionsSarcopenia

InterventionsPlacebo Exercise Non-Exercise HMB plus Vitamin D

DrugsHMB plus Vitamin D

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Sarcopenia
Sponsor: Metabolic Technologies Inc.
Enrollment: 238
Locations: 1
Primary Endpoint: Muscular strength
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

February 4, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Metabolic Technologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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).