Breakfast Meal Replacement

Overweight Clinical Trial

— MRP  

Official title:

Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482545
• Other study ID #: 15-0543
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: March 7, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Basal Metabolic Rate
• Body Composition, Beneficial
• Obese
• Overweight
• Satiety

Intervention

Dietary Supplement:
• Meal replacement

Locations

Country	Name	City	State
United States	Applied Physiology Laboratory	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fat Mass measured from multi-compartment (4C) model		0 to 8 weeks	No
Secondary	Change in lean mass measured from multi-compartment (4C) model		0 to 8 weeks	No
Secondary	Change in percent body fat measured from multi-compartment (4C) model		0 to 8 weeks	No
Secondary	Change in resting metabolic rate using indirect calorimetry		0 to 8 weeks	No
Secondary	Change in respiratory exchange ratio using indirect calorimetry		0 to 8 weeks	No
Secondary	Change in total leptin concentrations from blood sample analysis		0 to 8 weeks	No
Secondary	Change in LDL from blood sample analysis		0 to 8 weeks	No
Secondary	Change in triglycerides from blood sample analysis		0 to 8 weeks	No
Secondary	Change in insulin from blood sample analysis		0 to 8 weeks	No
Secondary	Change in visceral fat from ultrasonography		0 to 8 weeks	No
Secondary	Change in satiety via questionnaire		0 to 8 weeks	No