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

Not Applicable

Completed

• Conditions: Weight Loss; Obesity
• Interventions: Dietary Supplement: high protein; Dietary Supplement: standard protein

• Registration Number: NCT00523003
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1,	high protein	2.2 g protein/kg LBM/day high protein diet
2, standard protein	standard protein	1.1 g protein/kg LBM/day standard protein diet

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks

Secondary Outcome Measures

Name	Time	Method
Body composition, lipid panel	12 weeks