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Completed

NCT Number: NCT02043171

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Iowa State University

Ames, Iowa, 50010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

A Placebo comparator

HMB plus Vitamin D

Drug

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)

Non-Exercise

Behavioral

This group will not participate in 3 times per week strength training

Exercise

Behavioral

This group will participate in a supervised 3 times per week strength training program

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functionality

    Time frame: 12 months

    The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.

Other outcomes

  1. 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.

  2. Quality of life

    Time frame: 12 months

    Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • Iowa State University

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2014
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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