Breakfast Meal Replacement
MRP
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMarch 8, 2016
March 1, 2016
7 months
June 22, 2015
March 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Fat Mass measured from multi-compartment (4C) model
0 to 8 weeks
Secondary Outcomes (10)
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
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
- +5 more secondary outcomes
Study Arms (2)
Breakfast Meal Replacement
EXPERIMENTALOnce daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast.
Control
NO INTERVENTIONNo placebo or intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abbie Smith-Ryan
University of North Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 26, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03