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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443269
• Other study ID #: PRO-FY2022-183
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2022
• Source: University of Memphis
• Contact: Jacquelyn Pence, PhD
• Phone: 901-678-1547
• Email: jpence1[@]memphis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Dietary Supplement:
• Jump Start Nutritional Program
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

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	USANA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline	Day 8
Primary	Lipids Panel	Changes in lipids panel from baseline	Day 8
Primary	Glucose	Changes in glucose from baseline	Day 8
Primary	Insulin	Changes in insulin from baseline	Day 8
Primary	Body Weight	Changes in body weight from baseline	Day 8
Primary	Body Mass Index	Changes in body mass index from baseline	Day 8
Primary	Resting Blood pressure	Changes in resting blood pressure from baseline	Day 8
Primary	Resting Heart Rate	Changes in resting heart rate from baseline	Day 8
Primary	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
Primary	Hip Circumference	Changes in hip circumference from baseline	Day 8
Primary	Waist Circumference	Changes in waist circumference from baseline	Day 8
Primary	Physical Appearance	Changes in physical appearance of trunk region from bottom of neck to knee region	Day 8
Secondary	Diet	Changes in diet from before intervention determined using food logs	Day 8