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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00523003
First received: August 28, 2007
Last updated: October 16, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention
Weight Loss
Obesity
Dietary Supplement: high protein
Dietary Supplement: standard protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Body composition, lipid panel [ Time Frame: 12 weeks ]

Enrollment: 100
Study Start Date: May 2004
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 1,
2.2 g protein/kg LBM/day high protein diet
Dietary Supplement: high protein
2.2 g protein/kg of LBM per day
Placebo Comparator: 2, standard protein
1.1 g protein/kg LBM/day standard protein diet
Dietary Supplement: standard protein
1.1 g protein/kg LBM/day standard protein diet

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523003

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Zhaoping Li, MD, PhD California University, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523003     History of Changes
Other Study ID Numbers: 03-06-120
Study First Received: August 28, 2007
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
weight loss
obesity
high protein
meal replacement

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 15, 2014