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Breakfast Meal Replacement (MRP)

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ClinicalTrials.gov Identifier: NCT02482545
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Body Composition, Beneficial Basal Metabolic Rate Satiety Overweight Obese Dietary Supplement: Meal replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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



Primary Outcome Measures :
  1. Change in Fat Mass measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]

Secondary Outcome Measures :
  1. Change in lean mass measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]
  2. Change in percent body fat measured from multi-compartment (4C) model [ Time Frame: 0 to 8 weeks ]
  3. Change in resting metabolic rate using indirect calorimetry [ Time Frame: 0 to 8 weeks ]
  4. Change in respiratory exchange ratio using indirect calorimetry [ Time Frame: 0 to 8 weeks ]
  5. Change in total leptin concentrations from blood sample analysis [ Time Frame: 0 to 8 weeks ]
  6. Change in LDL from blood sample analysis [ Time Frame: 0 to 8 weeks ]
  7. Change in triglycerides from blood sample analysis [ Time Frame: 0 to 8 weeks ]
  8. Change in insulin from blood sample analysis [ Time Frame: 0 to 8 weeks ]
  9. Change in visceral fat from ultrasonography [ Time Frame: 0 to 8 weeks ]
  10. Change in satiety via questionnaire [ Time Frame: 0 to 8 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482545


Locations
United States, North Carolina
Applied Physiology Laboratory
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Abbie Smith-Ryan University of North Carolina

Responsible Party: Abbie Smith-Ryan, PhD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02482545     History of Changes
Other Study ID Numbers: 15-0543
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms