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 range18 Years – 45 Years

SexALL

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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…

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