Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Jump Start Nutritional Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of 28-39.9 kg/m2 can fast >10 hours maintain existing exercise regiment during study Exclusion Criteria: Weight greater than 500 lbs Type I or II diabetic liver disease tobacco user adversity to fiber or protein supplement taking weight loss dietary supplements or adhering to any weight loss plan in the month prior to and during participation in the study taking a multi-vitamin or pro-biotic, or if they were not recommended by a doctor, willing to stop for 4 weeks prior to the study. consumption of alcohol or caffeine within 24 hours of each testing visit strenuous exercise during the 24 hours period before each testing visit self-reported active infection or illness of any kind pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jump Start Program<br>The intervention consists of following the Jump Start plan for 7 days | Dietary Supplement: Jump Start Nutritional Program<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet | Changes in diet from before intervention determined using food logs | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jump Start, USANA