Viewing Study NCT00523003



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00523003
Status: COMPLETED
Last Update Posted: 2023-05-08
First Post: 2007-08-28

Brief Title: A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass
Sponsor: University of California Los Angeles
Organization: University of California Los Angeles

Study Overview

Official Title: A Controlled Trial of Protein Enrichment of Meal Replacements for Weight Reduction With Retention of Lean Body Mass
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 plans1 22 g proteinkg of LBM per day high protein diet HP or 2 11 g proteinkg LBMday 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 22 g proteinkg of LBM per day high protein diet HP or 2 11 g proteinkg LBMday 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None