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CompletedNCT02043171Updated Feb 11, 2019

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

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 →

Lead sponsor

Metabolic Technologies Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • Placebo comparator
    Placebo Exercise

    Placebo supplementation group with 3 days per week of exercise

    Dietary Supplement: Placebo · Behavioral: Exercise

  • Placebo comparator
    Placebo Non-exercise

    Placebo supplementation group without exercise

    Dietary Supplement: Placebo · Behavioral: Non-Exercise

  • Active comparator
    HMB plus Vitamin D Exercise

    HMB plus Vitamin D supplementation group with 3 days per week of exercise

    Drug: HMB plus Vitamin D · Behavioral: Exercise

  • Active comparator
    HMB plus Vitamin D Non-exercise

    HMB plus Vitamin D supplementation group without exercise

    Drug: HMB plus Vitamin D · Behavioral: Non-Exercise

Interventions

  • Dietary supplementPlacebo

    A Placebo comparator

  • DrugHMB plus Vitamin D

    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)

  • BehavioralNon-Exercise

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

  • BehavioralExercise

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Functionality

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

    Time frame: 12 months

Other outcomes

  1. 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

  2. Quality of life

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

    Time frame: 12 months

07

Study locations

1 site
  • Iowa State University
    Ames, Iowa 50010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02043171
Lead sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
Responsible party
Sponsor
First posted
Jan 23, 2014
Start date
Aug 2014
Primary completion
Feb 4, 2019
Completion
Feb 4, 2019
Last update
Feb 11, 2019

Study contacts

John A Rathmacher, PhD
principal investigator · Metabolic Technologies Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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