Breakfast Meal Replacement (MRP)

University of North Carolina (UNC)

Status

Completed

Conditions

Satiety

Obese

Overweight

Body Composition, Beneficial

Basal Metabolic Rate

Treatments

Dietary Supplement: Meal replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT02482545

15-0543

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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 pregnant or plans to become pregnant during the duration of the study
Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)