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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT00523003

Collaborator

National Institutes of Health (NIH) (NIH)

100

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Obesity	Dietary Supplement: high protein Dietary Supplement: standard protein	N/A

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 Design

Study Type:

Interventional

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 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Weight loss [12 weeks]

Secondary Outcome Measures

Body composition, lipid panel [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)