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

Last updated: May 22, 2025
Sponsor: University of California, Los Angeles
Overall Status: Completed

Phase

2/3

Condition

Weight Loss

Diabetes Prevention

Obesity

Treatment

Herbalife Meal Replacements

Clinical Study ID

NCT01030354
UCLA OPRS 03-06-120
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 30 years and older at screening

  2. Female subjects must have a negative pregnancy test at screening, must be surgicallysterile or at least 6 months postmenopausal or must use a form of birth controlmeasure. Hormonal birth control, IUD, or abstinence will be acceptable as birthcontrol measures. Other types of birth controls such as condom, diaphragm, orsponges may not be considered adequate forms of birth control measures in thisstudy.

  3. BMI of 27 to 40 kg/m2 inclusive.

  4. Subjects must be in good health as determined by medical history, physicalexamination, 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.

Exclusion

Exclusion Criteria:

  1. Weight Stability. Any subject who reports weight change of > 3.0 kg in the monthprior to screening.

  2. Any subject who has been on a very low calorie diet ( < 800 kcal/day) for a periodof 4 months or more in the 12 months prior to screening, or who has lost > 10 kg inthe 6 months prior to screening.

  3. Use of any other investigational drug (s) within 8 weeks prior to screening.

  4. 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 > 500mg/dl, total cholesterol > 350 mg/dl, TSH outside of normal range.

  5. Subjects who drink more than 1 alcoholic beverages per day.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Herbalife Meal Replacements
Phase: 2/3
Study Start date:
July 01, 2004
Estimated Completion Date:
December 31, 2005

Study Description

There is concern that excess protein intake may be damaging to liver, renal function, and bone health. This study was designed to compare the effects of a high protein (HP) and an isocaloric meal standard protein (SP) weight loss plan on liver function, renal function and bone metabolism.

Connect with a study center

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

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