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OpenTrials
Completed

NCT Number: NCT02482545

Breakfast Meal Replacement

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.

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Key information

Conditions

Body Composition, Beneficial Basal Metabolic Rate Body Weight Glucocorticoid Receptor Deficiency Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Satiety Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meal Replacement

Dietary Supplement

Primary outcomes

  1. Change in Fat Mass measured from multi-compartment (4C) model

    Time frame: 0 to 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: MRP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2015
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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