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

NCT ID: NCT05443269

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2022-09-30

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.

Conditions

Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Jump Start Program

The intervention consists of following the Jump Start plan for 7 days

Group Type: EXPERIMENTAL

Jump Start Nutritional Program

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USANA Health Sciences

INDUSTRY

Sponsor Role: collaborator

University of Memphis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacquelyn Pence, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Assistant Professor

Locations

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacquelyn Pence, PhD

Role: CONTACT

jpence1@memphis.edu

901-678-1547

Facility Contacts

Jacquelyn Pence, PhD

Role: primary

jpence1@memphis.edu

901-678-1547

Other Identifiers

PRO-FY2022-183

Identifier Type: -

Identifier Source: org_study_id