Breakfast Meal Replacement (MRP)
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|ClinicalTrials.gov Identifier: NCT02482545|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Body Composition, Beneficial Basal Metabolic Rate Satiety Overweight Obese||Dietary Supplement: Meal replacement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Breakfast Meal Replacement
Once daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast.
Dietary Supplement: Meal replacement
No Intervention: Control
No placebo or intervention
- Change in Fat Mass measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]
- Change in lean mass measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]
- Change in percent body fat measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]
- Change in resting metabolic rate using indirect calorimetry [ Time Frame: 0 to 8 weeks ]
- Change in respiratory exchange ratio using indirect calorimetry [ Time Frame: 0 to 8 weeks ]
- Change in total leptin concentrations from blood sample analysis [ Time Frame: 0 to 8 weeks ]
- Change in LDL from blood sample analysis [ Time Frame: 0 to 8 weeks ]
- Change in triglycerides from blood sample analysis [ Time Frame: 0 to 8 weeks ]
- Change in insulin from blood sample analysis [ Time Frame: 0 to 8 weeks ]
- Change in visceral fat from ultrasonography [ Time Frame: 0 to 8 weeks ]
- Change in satiety via questionnaire [ Time Frame: 0 to 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482545
|United States, North Carolina|
|Applied Physiology Laboratory|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Abbie Smith-Ryan||University of North Carolina|