A Controlled Trial of Protein Enrichment of Meal Replacem... | NCT00523003

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

NCT00523003

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

May 8, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Weight Loss
Obesity

Interventions

high protein
standard protein

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004Actual

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Aug 28, 2007

First Submission Date that Met QC Criteria

Aug 28, 2007

First Posted Date

Aug 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2023

Last Update Posted Date

May 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhaoping Li, Prinicpal Investigator, University of California, Los AngelesPrincipal Investigator

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1,	Experimental	2.2 g protein/kg LBM/day high protein diet	Dietary Supplement: high protein
2, standard protein	Placebo Comparator	1.1 g protein/kg LBM/day standard protein diet	Dietary Supplement: standard protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high protein	Dietary Supplement	2.2 g protein/kg of LBM per day	1,

Measure	Description	Time Frame
Weight loss		12 weeks

Measure	Description	Time Frame
Body composition, lipid panel		12 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhaoping Li, MD, PhD	California University, Los Angeles	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss
D009765	Obesity

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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