Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Iowa State University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Exercise | Placebo Comparator | Placebo supplementation group with 3 days per week of exercise |
|
| Placebo Non-exercise | Placebo Comparator | Placebo supplementation group without exercise |
|
| HMB plus Vitamin D Exercise | Active Comparator | HMB plus Vitamin D supplementation group with 3 days per week of exercise |
|
| HMB plus Vitamin D Non-exercise | Active Comparator | HMB plus Vitamin D supplementation group without exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | A Placebo comparator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular strength | Leg and elbow strength will be tested by Isokinetic dynamometer and Handgrip strength will be tested using a hand-grip dynamometer. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Functionality | The Get-Up and Get-Up-and-Go tests will be used as a measure of functionality. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Quality of life |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John A Rathmacher, PhD | Metabolic Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa State University | Ames | Iowa | 50010 | United States |
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HMB plus Vitamin D |
| Drug |
Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d) |
|
|
| 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 |
|
Questionnaires will be administered to assess feeling, general health, the IPAQ, cognitive functioning, and SF-36.
| 12 months |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |