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

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ClinicalTrials.gov Identifier: NCT00523003
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : October 17, 2008
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Weight Loss Obesity Dietary Supplement: high protein Dietary Supplement: standard protein Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass
Study Start Date : May 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00523003


Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
Principal Investigator: Zhaoping Li, MD, PhD California University, Los Angeles

ClinicalTrials.gov Identifier: NCT00523003     History of Changes
Other Study ID Numbers: 03-06-120
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes