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: Completed
• Conditions: Overweight; Obese; Body Composition, Beneficial; Satiety; Basal Metabolic Rate
• Intervention / Treatment: Dietary supplement: Meal replacement

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Number of Arms

2

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.	Dietary supplement: Meal replacement
NO_INTERVENTION: Control; No placebo or intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Fat Mass measured from multi-compartment (4C) model	0 to 8 weeks

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Abbie Smith-Ryan, University of North Carolina

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (ESTIMATE): June 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 15-0543