NCT02482545

Breakfast Meal Replacement

Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Composition, Beneficial
• Basal Metabolic Rate
• Satiety
• Overweight
• Obese

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Meal replacement

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-06-26
• Last updated: 2016-03-08

Locations

1 site across 1 country: United States