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A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass

Primary Purpose

Weight Loss, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high protein
standard protein
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring weight loss, obesity, high protein, meal replacement

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • body mass index (BMI) between 27 to 40 kg/m2
  • in good health by history, physical examination, and basic laboratory screening (complete blood count, serum chemistries, liver panel, and lipid panel)

Exclusion Criteria:

  • type 2 diabetes or glucose intolerance
  • regularly drank more than one alcoholic beverage daily
  • unable to provide consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1,

    2, standard protein

    Arm Description

    2.2 g protein/kg LBM/day high protein diet

    1.1 g protein/kg LBM/day standard protein diet

    Outcomes

    Primary Outcome Measures

    Weight loss

    Secondary Outcome Measures

    Body composition, lipid panel

    Full Information

    First Posted
    August 28, 2007
    Last Updated
    May 4, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00523003
    Brief Title
    A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass
    Official Title
    A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (Actual)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study hypothesis: High protein diets have been shown to make people full and and help to retent of muscle mass. This study was designed to determine effects of a protein- enriched meal replacement (MR) on weight loss and muscle mass retention by comparison to an equal calorie carbohydrate-enriched MR. Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two equal calorie meal plans.,1) 2.2 g protein/kg of LBM per day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks.
    Detailed Description
    Background: While high protein diets have been shown to improve satiety and retention of lean body mass (LBM), this study was designed to determine effects of a protein- enriched meal replacement (MR) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or standard protein intakes. Methods: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a standard MR to which was added supplementary protein or carbohydrate powder. MR were used twice daily (one meal, one snack). One additional meal was included in the meal plan designed to achieve individualized protein intakes of either 1) 2.2 g protein/kg of LBM per day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). LBM was determined using bioelectrical impedance analysis (BIA). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss, Obesity
    Keywords
    weight loss, obesity, high protein, meal replacement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1,
    Arm Type
    Experimental
    Arm Description
    2.2 g protein/kg LBM/day high protein diet
    Arm Title
    2, standard protein
    Arm Type
    Placebo Comparator
    Arm Description
    1.1 g protein/kg LBM/day standard protein diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    high protein
    Intervention Description
    2.2 g protein/kg of LBM per day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    standard protein
    Intervention Description
    1.1 g protein/kg LBM/day standard protein diet
    Primary Outcome Measure Information:
    Title
    Weight loss
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Body composition, lipid panel
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: body mass index (BMI) between 27 to 40 kg/m2 in good health by history, physical examination, and basic laboratory screening (complete blood count, serum chemistries, liver panel, and lipid panel) Exclusion Criteria: type 2 diabetes or glucose intolerance regularly drank more than one alcoholic beverage daily unable to provide consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhaoping Li, MD, PhD
    Organizational Affiliation
    California University, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass

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