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Lack of recruitment of subjects.
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| Name | Class |
|---|---|
| Iowa State University | OTHER |
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This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Diet Restriction | Placebo Comparator |
| |
| Placebo No Diet Restriction | Placebo Comparator |
| |
| HMB Diet Restriction | Active Comparator |
| |
| HMB No Diet Restriction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo capsules containing calcium lactate similar to the HMB capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of bone mineral density | Bone mineral density measured by DXA (T-score) | 8 weeks |
| Maintenance of lean mass | Lean Mass measured by DXA (kg) | 8 weeks |
| Maintenance of muscle strength | Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m) | 8 weeks |
| Maintenance of hand muscle strength | Hand muscle strength will be assessed using hand grips (kg) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudy Valentine, PhD | Iowa State University | Principal Investigator |
| John A Rathmacher, PhD | Metabolic Technologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa State University | Ames | Iowa | 50011 | United States |
No Individual Data will be shared. Data summaries will be available after publication..
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| ID | Term |
|---|---|
| D009765 | Obesity |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| HMB | Dietary Supplement | HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |