Back to resultsNutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
Primary Purpose
Sarcopenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
HMB plus Vitamin D
Non-Exercise
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
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.
- 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.
Sites / Locations
- Iowa State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo Exercise
Placebo Non-exercise
HMB plus Vitamin D Exercise
HMB plus Vitamin D Non-exercise
Arm Description
Placebo supplementation group with 3 days per week of exercise
Placebo supplementation group without exercise
HMB plus Vitamin D supplementation group with 3 days per week of exercise
HMB plus Vitamin D supplementation group without exercise
Outcomes
Primary Outcome Measures
Muscular strength
Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer.
Secondary Outcome Measures
Functionality
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
Full Information
NCT ID
NCT02043171
First Posted
January 17, 2014
Last Updated
February 7, 2019
Sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
1. Study Identification
Unique Protocol Identification Number
NCT02043171
Brief Title
Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Exercise
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation group with 3 days per week of exercise
Arm Title
Placebo Non-exercise
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation group without exercise
Arm Title
HMB plus Vitamin D Exercise
Arm Type
Active Comparator
Arm Description
HMB plus Vitamin D supplementation group with 3 days per week of exercise
Arm Title
HMB plus Vitamin D Non-exercise
Arm Type
Active Comparator
Arm Description
HMB plus Vitamin D supplementation group without exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
A Placebo comparator
Intervention Type
Drug
Intervention Name(s)
HMB plus Vitamin D
Other Intervention Name(s)
HMB (Calcium beta-hydroxy-beta-methylbutyrate), Vitamin D (Cholecalciferol)
Intervention Description
Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)
Intervention Type
Behavioral
Intervention Name(s)
Non-Exercise
Intervention Description
This group will not participate in 3 times per week strength training
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
This group will participate in a supervised 3 times per week strength training program
Primary Outcome Measure Information:
Title
Muscular strength
Description
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 Outcome Measure Information:
Title
Functionality
Description
The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Muscle mass
Description
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
Title
Quality of life
Description
Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Rathmacher, PhD
Organizational Affiliation
Metabolic Technologies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
12. IPD Sharing Statement
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Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
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