NCT05443269

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 29, 2022

Last Update Submit

June 29, 2022

Conditions

Weight Loss

Keywords

Jump StartUSANA

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • Diet

    Day 8

Study Arms (1)

Jump Start Program

EXPERIMENTAL

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

Dietary Supplement: Jump Start Nutritional Program

Interventions

Jump Start Nutritional ProgramDIETARY_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

Jump Start Program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 28-39.9 kg/m2
  • can fast \>10 hours
  • maintain existing exercise regiment during study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38156, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacquelyn Pence, PhD

    Research Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacquelyn Pence, PhD

CONTACT

901-678-1547jpence1@memphis.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 5, 2022

Study Start

February 14, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

US(1)