Clinical trial NCT02482545: Breakfast Meal Replacement
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition, Beneficial
Basal Metabolic Rate
Satiety
Overweight
Obese
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Fat Mass measured from multi-compartment (4C) model
timeFrame: 0 to 8 weeks
Secondary outcomes:
measure: Change in lean mass measured from multi-compartment (4C) model
timeFrame: 0 to 8 weeks
measure: Change in percent body fat measured from multi-compartment (4C) model
timeFrame: 0 to 8 weeks
measure: Change in resting metabolic rate using indirect calorimetry
timeFrame: 0 to 8 weeks
measure: Change in respiratory exchange ratio using indirect calorimetry
timeFrame: 0 to 8 weeks
measure: Change in total leptin concentrations from blood sample analysis
timeFrame: 0 to 8 weeks
measure: Change in LDL from blood sample analysis
timeFrame: 0 to 8 weeks
measure: Change in triglycerides from blood sample analysis
timeFrame: 0 to 8 weeks
measure: Change in insulin from blood sample analysis
timeFrame: 0 to 8 weeks
measure: Change in visceral fat from ultrasonography
timeFrame: 0 to 8 weeks
measure: Change in satiety via questionnaire
timeFrame: 0 to 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Abbie Smith-Ryan
role: PRINCIPAL_INVESTIGATOR
References: