- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482545
Breakfast Meal Replacement (MRP)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Applied Physiology Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Breakfast Meal Replacement
Once daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast.
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NO_INTERVENTION: Control
No placebo or intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Fat Mass measured from multi-compartment (4C) model
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in lean mass measured from multi-compartment (4C) model
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in percent body fat measured from multi-compartment (4C) model
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in resting metabolic rate using indirect calorimetry
Time Frame: 0 to 8 weeks
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0 to 8 weeks
|
Change in respiratory exchange ratio using indirect calorimetry
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in total leptin concentrations from blood sample analysis
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in LDL from blood sample analysis
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in triglycerides from blood sample analysis
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in insulin from blood sample analysis
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in visceral fat from ultrasonography
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Change in satiety via questionnaire
Time Frame: 0 to 8 weeks
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0 to 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Abbie Smith-Ryan, University of North Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0543
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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