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| Name | Class |
|---|---|
| USANA Health Sciences | INDUSTRY |
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The purpose of the proposed study is to evaluate the impact of the Jump Start program to facilitate weight loss in a sample of overweight and obese men and women. The study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. This study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. The hypothesis is that the Jump Start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jump Start Program | Experimental | The intervention consists of following the Jump Start plan for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jump Start Nutritional Program | Dietary Supplement | Nutri-meal Active meal replacement shake and Metabolism pill at breakfast, lunch, and dinner, morning and evening Health Pak (multivitamin), 1 probiotic stick, and 300 calories fruits and vegetables daily |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline | Day 8 |
| Lipids Panel | Changes in lipids panel from baseline | Day 8 |
| Glucose | Changes in glucose from baseline | Day 8 |
| Insulin | Changes in insulin from baseline | Day 8 |
| Body Weight | Changes in body weight from baseline | Day 8 |
| Body Mass Index | Changes in body mass index from baseline | Day 8 |
| Resting Blood pressure | Changes in resting blood pressure from baseline | Day 8 |
| Resting Heart Rate | Changes in resting heart rate from baseline | Day 8 |
| Subjects' perceived wellness | Changes in subjects perceived wellness from baseline using a visual analog scale from 0 to 10 with 0 being very low and 10 being extremely high |
| Measure | Description | Time Frame |
|---|---|---|
| Diet | Changes in diet from before intervention determined using food logs | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacquelyn Pence, PhD | Contact | 901-678-1547 | jpence1@memphis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn Pence, PhD | Research Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutraceutical and Dietary Supplement Research | Recruiting | Memphis | Tennessee | 38156 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 10, 2023 | |
| Reset | Apr 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 10, 2023 | Apr 5, 2024 |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 8 |
| Hip Circumference | Changes in hip circumference from baseline | Day 8 |
| Waist Circumference | Changes in waist circumference from baseline | Day 8 |
| Physical Appearance | Changes in physical appearance of trunk region from bottom of neck to knee region | Day 8 |