Weight LossNCT05443269
Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures
A study testing Jump Start Nutritional Program in people with Weight Loss, run by University of Memphis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Jump Start Nutritional Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 28-39.9 kg/m2
- can fast >10 hours
- maintain existing exercise regiment during study
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38156
Jacquelyn Pence, PhD, 901-678-1547, jpence1@memphis.edu
About this study
Official title: 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.
- Conditions
- Weight Loss
- Being tested
- Jump Start Nutritional Program
- Keywords
- Jump Start, USANA
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Jump Start Program | Experimental | The intervention consists of following the Jump Start plan for 7 days Receives: Dietary Supplement: Jump Start Nutritional Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline
Measured: Day 8
Lipids Panel
Changes in lipids panel from baseline
Measured: Day 8
Glucose
Changes in glucose from baseline
Measured: Day 8
Insulin
Changes in insulin from baseline
Measured: Day 8
Body Weight
Changes in body weight from baseline
Measured: Day 8
Body Mass Index
Changes in body mass index from baseline
Measured: Day 8
Resting Blood pressure
Changes in resting blood pressure from baseline
Measured: Day 8
Resting Heart Rate
Changes in resting heart rate from baseline
Measured: 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
Measured: Day 8
Hip Circumference
Changes in hip circumference from baseline
Measured: Day 8
Waist Circumference
Changes in waist circumference from baseline
Measured: Day 8
Physical Appearance
Changes in physical appearance of trunk region from bottom of neck to knee region
Measured: Day 8
Secondary outcomes (1)
Diet
Changes in diet from before intervention determined using food logs
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start14 Feb 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- USANA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Jacquelyn Pence, PhD, Principal investigator, Research Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443269
- Sponsor's protocol ID
- PRO-FY2022-183
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
- ClinicalTrials.gov ID
- NCT05443269
- Acronym / sponsor ID
- PRO-FY2022-183
- Conditions
- Weight Loss
- Keywords
- Jump Start, USANA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- USANA Health Sciences
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jump Start Program | Experimental | Dietary Supplement: Jump Start Nutritional ProgramThe intervention consists of following the Jump Start plan for 7 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI of 28-39.9 kg/m2
- can fast >10 hours
- maintain existing exercise regiment during study
Key exclusion criteria (11 listed)
- Weight greater than 500 lbs
- Type I or II diabetic
- liver disease
- tobacco user
- adversity to fiber or protein supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jump Start Nutritional ProgramNutri-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 | Dietary supplement | Jump Start Program |
Primary outcome
Body Composition
Time frame: Day 8
Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline
Lipids Panel
Time frame: Day 8
Changes in lipids panel from baseline
Glucose
Time frame: Day 8
Changes in glucose from baseline
Insulin
Time frame: Day 8
Changes in insulin from baseline
Body Weight
Time frame: Day 8
Changes in body weight from baseline
Body Mass Index
Time frame: Day 8
Changes in body mass index from baseline
Resting Blood pressure
Time frame: Day 8
Changes in resting blood pressure from baseline
Resting Heart Rate
Time frame: Day 8
Changes in resting heart rate from baseline
Subjects' perceived wellness
Time frame: Day 8
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
Time frame: Day 8
Changes in hip circumference from baseline
Waist Circumference
Time frame: Day 8
Changes in waist circumference from baseline
Physical Appearance
Time frame: Day 8
Changes in physical appearance of trunk region from bottom of neck to knee region
1 secondary outcome
Diet
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelyn Pence, PhD principal investigator
Research Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jump Start Nutritional Program in people with Weight Loss, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacquelyn Pence, PhD (901-678-1547, jpence1@memphis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: Day 8). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.