- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043171
Nutritional Intervention for Age-related Muscular Function and Strength Losses-Study 2
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Iowa State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Sarcopenia
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- MTI2014-CS01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Sarcopenia
-
University of Texas at AustinNot yet recruitingExercise Training and SarcopeniaUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Creighton UniversityUniversity of NebraskaRecruiting
-
University Hospital, CaenCompleted
-
University of NottinghamUniversity of OxfordRecruitingMuscle Atrophy | Age-Related SarcopeniaUnited Kingdom
-
Tufts UniversityNational Institute on Aging (NIA)CompletedMuscle Loss | Age-Related SarcopeniaUnited States
-
China Medical University HospitalCompleted
-
King's College LondonCo-sponsor: Guy's and St Thomas' NHS Foundation TrustCompletedFrailty | Sarcopenia | Age-Related SarcopeniaUnited Kingdom
-
Norwegian School of Sport SciencesOslo University HospitalNot yet recruitingHealthy Aging | Testosterone Deficiency | Age-Related Sarcopenia
-
Ningbo Medical Center Lihuili HospitalCompletedHemodialysis Patients With SarcopeniaChina
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States