NCT00523003

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

August 28, 2007

Last Update Submit

May 4, 2023

Conditions

Weight LossObesity

Keywords

weight lossobesityhigh proteinmeal replacement

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    12 weeks

Secondary Outcomes (1)

  • Body composition, lipid panel

    12 weeks

Study Arms (2)

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

high proteinDIETARY_SUPPLEMENT

2.2 g protein/kg of LBM per day

1,
standard proteinDIETARY_SUPPLEMENT

1.1 g protein/kg LBM/day standard protein diet

2, standard protein

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • type 2 diabetes or glucose intolerance
  • regularly drank more than one alcoholic beverage daily
  • unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Zhaoping Li, MD, PhD

    California University, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

May 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 8, 2023

Record last verified: 2023-05