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| Name | Class |
|---|---|
| Utah State University | OTHER |
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The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and Low Fat Eating Plan | Placebo Comparator | Placebo Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Placebo Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Placebo Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) The placebo group will be instructed to consume every day, a low fat standard of care eating plan delivering approximately 1200-1500 Kcals. |
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| Dietary Supplements and TR90 Eating Plan | Experimental | Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) Experimental group will be instructed to consume every day, dietary supplements and a moderate protein eating plan delivering approximately 1200-1500 Kcals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplements and TR90 Eating Plan | Dietary Supplement | Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of a novel weight management program on body fat mass over 90 days. | Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner. | Days 0 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events) | Throughout 1 year | |
| Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lefevre, PhD | Utah State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Utah State University | Logan | Utah | 84322 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo and Low Fat Eating Plan | Dietary Supplement |
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| throughout 1 year |
| Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing) | Throughout 1 year |
| Determine skin carotenoid (Biophotonic Scanner) measurement changes. | Biophotonic Scanner utilizes raman spectroscopy to determine skin carotenoid concentrations. | Throughout 1 year |
| Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90. | Leptin, Insulin, Adiponectin, Pancreatic Polypeptide, gLP1, C-peptide, Glucagon, Resistin and HbA1c | Days 0 and 90 |
| Evaluate the changes in inflammatory markers from the baseline visit to day 90. | hsCRP, IL-6 and TNF Receptors 60 and 80 | Days 0 and 90 |
| Evaluate the changes in gene expression from the baseline visit to day 90. | Full gene arrays will be made on peripheral blood mononuclear cells. The gene expression changes will be made at baseline and day 90. There will also be a comparison back to proteins (i.e. hormones and inflammatory markers). | Day 0 and 90 |
| Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365. | Resting metabolic rate (RMR)and substrate utilization (R-values to determine wheather subjects are utilizing more fats or carbohydrates to meet energy demands) will be measured by CPET Quark. | Days 0, 90, 80, and 365 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |