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

February 7, 2019 updated by: Metabolic Technologies Inc.

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.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Iowa
      • Ames, Iowa, United States, 50010
        • Iowa State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Willing to participate in 3-day-a-week monitored strength-training program.
  • Physician has placed no restriction on physical exercise.

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).
  • Subjects with serum 25OH-vitD3 <10 ng/ml will be considered deficient and will be referred to their physician for treatment.
  • Subjects with serum 25OH-vitD3 >30 ng/ml may not respond to the intervention as expected and will also be excluded from the study.
  • Not able or willing to participate in 3-day-a-week monitored strength-training program.
  • Physician has placed a restriction on physical exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Exercise
Placebo supplementation group with 3 days per week of exercise
A Placebo comparator
This group will participate in a supervised 3 times per week strength training program
Placebo Comparator: Placebo Non-exercise
Placebo supplementation group without exercise
A Placebo comparator
This group will not participate in 3 times per week strength training
Active Comparator: HMB plus Vitamin D Exercise
HMB plus Vitamin D supplementation group with 3 days per week of exercise
This group will participate in a supervised 3 times per week strength training program
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)
Active Comparator: HMB plus Vitamin D Non-exercise
HMB plus Vitamin D supplementation group without exercise
This group will not participate in 3 times per week strength training
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular strength
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality
Time Frame: 12 months
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
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.
12 months
Quality of life
Time Frame: 12 months
Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

February 4, 2019

Study Completion (Actual)

February 4, 2019

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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