Overweight Clinical Trial
Official title:
Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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