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
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring weight loss, obesity, high protein, meal replacement
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
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
NCT ID
NCT00523003
First Posted
August 28, 2007
Last Updated
May 4, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
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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