Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-06-30
2016-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Breakfast Meal Replacement
Once daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast.
Meal replacement
Control
No placebo or intervention
No interventions assigned to this group
Interventions
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Meal replacement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
45 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Abbie Smith-Ryan, PhD
Assistant Professor
Principal Investigators
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Abbie Smith-Ryan
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Applied Physiology Laboratory
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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15-0543
Identifier Type: -
Identifier Source: org_study_id
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