Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial

NCT01030354 | Completed Phase 2

• 1 other identifier: UCLA OPRS 03-06-120
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether a higher protein meal replacement diet (consisting of 1 gram of protein per pound lean body mass) is more effective in causing weight loss compared to a standard meal replacement protein diet (consisting of ½ gram of protein per pound of lean body mass). The study will assign approximately 100 subjects (50 each) to the following arms 1) higher meal replacement diet program 2) standard meal replacement diet program. All participants will meet with a registered dietitian to provide nutrition education and behavior modification, including general exercise recommendations. As part of your participation, you must be willing to undergo a measurement of body fat, and blood tests, and be willing to use Herbalife Meal replacements as part of your diet for the duration of the study (one year).

Conditions

Weight Reduction; Obesity; Weight Management

Keywords

Satiety; Meal Replacements; High Protein; Standard Protein

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the change in weight.

  Baseline, 3, 6 and 12 months

Secondary Outcomes (1)

• Secondary endpoints are changes in fasting plasma glucose levels associated with weight loss, insulin, blood pressure, lipid levels and body fat.

  Baseline and 12 months

Study Arms (2)

Dietary Intervention and Higher protein meal replacement

ACTIVE COMPARATOR

A higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass

Dietary Supplement: Herbalife Meal Replacements

Dietary Intervention and Standard Protein Meal Replacement

ACTIVE COMPARATOR

Standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass

Dietary Supplement: Herbalife Meal Replacements

Interventions

Herbalife Meal Replacements DIETARY_SUPPLEMENT

Higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass will improve weight loss in comparison to a standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass

Dietary Intervention and Higher protein meal replacement; Dietary Intervention and Standard Protein Meal Replacement

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 years and older at screening
• Female subjects must have a negative pregnancy test at screening, must be surgically sterile or at least 6 months postmenopausal or must use a form of birth control measure. Hormonal birth control, IUD, or abstinence will be acceptable as birth control measures. Other types of birth controls such as condom, diaphragm, or sponges may not be considered adequate forms of birth control measures in this study.
• BMI of 27 to 40 kg/m2 inclusive.
• Subjects must be in good health as determined by medical history, physical examination, and screening clinical laboratory including chemistry panel and CBC.
• h. Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
• i. Subjects requiring the regular use of any prescription medication may be admitted to the study providing the dose is stable.
• j. Ethical
• Subject must sign the Institutional Review Board-approved written informed consent prior to he initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.

You may not qualify if:

• Weight Stability. Any subject who reports weight change of \> 3.0 kg in the month prior to screening.
• Any subject who has been on a very low calorie diet ( \< 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost \> 10 kg in the 6 months prior to screening.
• Use of any other investigational drug (s) within 8 weeks prior to screening.
• Abnormal laboratory parameters: Serum creatinine \> 1.6 mg/dl, Liver function tests, ALT, AST, Bili results \> 2.0 times the upper limit of normal. Triglycerides \> 500 mg/dl, total cholesterol \> 350 mg/dl, TSH outside of normal range.
• Subjects who drink more than 1 alcoholic beverages per day.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator
• Herbalife International of America, Inc.: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Li Z, Treyzon L, Chen S, Yan E, Thames G, Carpenter CL. Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial. Nutr J. 2010 Dec 31;9:72. doi: 10.1186/1475-2891-9-72.

  PMID: 21194471 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: July 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (1)