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

Primary Purpose

Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jump Start Nutritional Program
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight Loss focused on measuring Jump Start, USANA

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Nutraceutical and Dietary Supplement ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jump Start Program

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diet
Changes in diet from before intervention determined using food logs

Full Information

First Posted
June 29, 2022
Last Updated
June 29, 2022
Sponsor
University of Memphis
Collaborators
USANA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05443269
Brief Title
Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures
Official Title
Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Memphis
Collaborators
USANA Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Jump Start, USANA

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jump Start Program
Arm Type
Experimental
Arm Description
The intervention consists of following the Jump Start plan for 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Jump Start Nutritional Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Body Composition
Description
Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline
Time Frame
Day 8
Title
Lipids Panel
Description
Changes in lipids panel from baseline
Time Frame
Day 8
Title
Glucose
Description
Changes in glucose from baseline
Time Frame
Day 8
Title
Insulin
Description
Changes in insulin from baseline
Time Frame
Day 8
Title
Body Weight
Description
Changes in body weight from baseline
Time Frame
Day 8
Title
Body Mass Index
Description
Changes in body mass index from baseline
Time Frame
Day 8
Title
Resting Blood pressure
Description
Changes in resting blood pressure from baseline
Time Frame
Day 8
Title
Resting Heart Rate
Description
Changes in resting heart rate from baseline
Time Frame
Day 8
Title
Subjects' perceived wellness
Description
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
Time Frame
Day 8
Title
Hip Circumference
Description
Changes in hip circumference from baseline
Time Frame
Day 8
Title
Waist Circumference
Description
Changes in waist circumference from baseline
Time Frame
Day 8
Title
Physical Appearance
Description
Changes in physical appearance of trunk region from bottom of neck to knee region
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Diet
Description
Changes in diet from before intervention determined using food logs
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquelyn Pence, PhD
Phone
901-678-1547
Email
jpence1@memphis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacquelyn Pence, PhD
Organizational Affiliation
Research Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Nutraceutical and Dietary Supplement Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquelyn Pence, PhD
Phone
901-678-1547
Email
jpence1@memphis.edu

12. IPD Sharing Statement

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

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