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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Jump Start Nutritional Program

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacquelyn Pence, PhD; Phone Number: 901-678-1547; Email: jpence1@memphis.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38156
      • Recruiting
      • Center for Nutraceutical and Dietary Supplement Research
      • Contact: Jacquelyn Pence, PhD; Phone Number: 901-678-1547; Email: jpence1@memphis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jump Start Program; The intervention consists of following the Jump Start plan for 7 days	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: USANA Health Sciences
• Investigators: Principal Investigator: Jacquelyn Pence, PhD, Research Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Jump Start; USANA
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: PRO-FY2022-183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No