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| Name | Class |
|---|---|
| Nu Skin Enterprises | INDUSTRY |
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Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period
Safety assessment:
Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the nutritional supplement.
Efficacy Assessment:
The objectives of this study are to evaluate the efficacy (changes in body composition and measurements as well as influence on appetite and quality of life changes) of the nutritional supplement administered repeatedly throughout the study.
Study Subject Population:
Healthy adult men and women are eligible for participation upon fulfillment of the inclusion/exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement | Experimental | Treatment Regimen -The Nutritional Supplement will be given for approximately 90 days in the form of 7 capsules and a powder to mix into liquids or foods for the first 15 days of program. Subjects will also drink a protein shake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplement and protein shakes | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| -Evaluate the changes in body composition as determined by percent body fat using the Bod Pod | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the changes in body weight |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Poole, BS | Pharmanex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
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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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| 90 days |