Status:
COMPLETED
Nutritional Intervention for Age-related Muscular Function and Strength Losses
Lead Sponsor:
Metabolic Technologies Inc.
Collaborating Sponsors:
Iowa State University
South Dakota State University
Conditions:
Muscle Strength
Sarcopenia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to * Test the effect of a dietary supplement beta-hydroxy-beta-methylbutyrate (HMB) with and without Vitamin D to prevent and reverse the losses of muscular strength and f...
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria in order to participate in the study.
- 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 (i.e., bone density \> 2.5 standard deviations below the mean) will not be enrolled in the study.
- No other serious medical illness.
- Serum 25OH-VitD3 \>10 and \<25 ng/ml.
- Able and willing to participate in 3-day-a-week monitored strength-training program.
- Physician has placed no restriction on physical exercise.
- All candidates meeting any one of the exclusion criteria will not be enrolled into the study and as necessary will be referred to their private physician for further follow-up.
- 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 (i.e., bone density \> 2.5 standard deviations below the mean) will not be enrolled in the study.
- Other serious medical illness, which the subjects doctor or medical review team has decided affects the subject's ability to participate in the study.
- 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 \>25 ng/ml.
- Not able or willing to participate in 3-day-a-week monitored strength-training program.
- Physician has placed a restriction on physical exercise.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00874575
Start Date
November 1 2008
End Date
July 1 2013
Last Update
September 17 2014
Active Locations (2)
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1
Iowa State University
Ames, Iowa, United States, 50010
2
South Dakota State University
Brookings, South Dakota, United States, 57007