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

Not Applicable

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Jump Start Nutritional Program

• Registration Number: NCT05443269
• Lead Sponsor: University of Memphis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Status Verified: 2022-06
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Last Update Submitted: 2022-06-29
• Study First Posted: 2022-07-05
• Last Update Posted: 2022-07-05
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jump Start Program	Jump Start Nutritional Program	The intervention consists of following the Jump Start plan for 7 days

Primary Outcome Measures

Name	Time	Method
Body Composition	Day 8	Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline
Lipids Panel	Day 8	Changes in lipids panel from baseline
Glucose	Day 8	Changes in glucose from baseline
Insulin	Day 8	Changes in insulin from baseline
Body Weight	Day 8	Changes in body weight from baseline
Body Mass Index	Day 8	Changes in body mass index from baseline
Resting Blood pressure	Day 8	Changes in resting blood pressure from baseline
Resting Heart Rate	Day 8	Changes in resting heart rate from baseline
Subjects' perceived wellness	Day 8	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
Hip Circumference	Day 8	Changes in hip circumference from baseline
Waist Circumference	Day 8	Changes in waist circumference from baseline
Physical Appearance	Day 8	Changes in physical appearance of trunk region from bottom of neck to knee region

Secondary Outcome Measures

Name	Time	Method
Diet	Day 8	Changes in diet from before intervention determined using food logs

Trial Locations

Locations (1)

Center for Nutraceutical and Dietary Supplement Research; 🇺🇸 Memphis, Tennessee, United States