CompletedNot Applicable

Breakfast Meal Replacement

United States50 participantsStarted 2015-06

Plain-language summary

Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition. Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Procedures (methods): In a randomized control intervention, subjects will complete 5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing sessions) as well as an 8 week intervention period. Pre-screening will include written informed consent, health history questionnaire, nutrition analysis, and baseline anthropometric measures. Baseline testing will be split into two sessions and include measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones, mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory fitness assessment. Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement to be taken at breakfast) and control groups (continue normal eating habits) with 4 electronic correspondences throughout the supplementation period. All measures will be repeated in two post-testing sessions.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy, Overweight Men and Pre-Menopausal Women * Participant agrees to maintain usual activity lifestyle * Participant has a body mass index of ≥ 28 (men) and ≥25 (women) kg/m2 and/or %body fat of ≥ 25% * Participant has provided written and dated informed consent to participate in the study * Participant is willing and able to comply with the protocol * Participant is apparently healthy and free from disease, as determined by a health history questionnaire (diabetes, heart disease, kidney disease, cancer, thyroid disorder, etc). * Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days * Participant has stated a goal of losing weight or improving body composition Exclusion Criteria: * Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders (i.e. anything influencing exercise ability). * Participant is using, or has used one of the following dietary supplements within 8 weeks prior to enrollment: Meal replacement shakes, Whey Protein, Beta-alanine, Creatine, beta-hydroxy beta methylbutyrate, Carnosine or Taurine * Participant has lost or gained greater than ten pounds within the previous 3 months * Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment * Participant had or currently has a self-identified eating disorder * Participant is pr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fat Mass measured from multi-compartment (4C) model

Timeframe: 0 to 8 weeks

Trial details

NCT IDNCT02482545

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Body Composition, Beneficial trials