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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast Meal Replacement | Experimental | Once daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast. |
|
| Control | No Intervention | No placebo or intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal replacement | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Mass measured from multi-compartment (4C) model | 0 to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean mass measured from multi-compartment (4C) model | 0 to 8 weeks | |
| Change in percent body fat measured from multi-compartment (4C) model | 0 to 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Physiology Laboratory | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| C564221 | Glucocorticoid Receptor Deficiency |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Change in resting metabolic rate using indirect calorimetry |
| 0 to 8 weeks |
| Change in respiratory exchange ratio using indirect calorimetry | 0 to 8 weeks |
| Change in total leptin concentrations from blood sample analysis | 0 to 8 weeks |
| Change in LDL from blood sample analysis | 0 to 8 weeks |
| Change in triglycerides from blood sample analysis | 0 to 8 weeks |
| Change in insulin from blood sample analysis | 0 to 8 weeks |
| Change in visceral fat from ultrasonography | 0 to 8 weeks |
| Change in satiety via questionnaire | 0 to 8 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |