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

This study has been completed.
Sponsor:
Collaborators:
Herbalife, International, Los Angeles, California
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01030354
First received: December 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

December 10, 2009
December 10, 2009
July 2004
July 2005   (final data collection date for primary outcome measure)
The primary efficacy endpoint is the change in weight. [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Secondary endpoints are changes in fasting plasma glucose levels associated with weight loss, insulin, blood pressure, lipid levels and body fat. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial
Not Provided

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Weight Reduction
  • Obesity
  • Weight Management
  • Dietary Supplement: Herbalife Meal Replacements
    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
    Other Name: Herbalife Meal Replacements
  • Dietary Supplement: Herbalife Meal Replacements
    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.
    Other Name: Herbalife Meal Replacements
  • Active Comparator: Dietary Intervention and Higher protein meal replacement
    A higher protein meal replacement diet based on 1 gram of protein per pound of lean body mass
    Interventions:
    • Dietary Supplement: Herbalife Meal Replacements
    • Dietary Supplement: Herbalife Meal Replacements
  • Active Comparator: Dietary Intervention and Standard Protein Meal Replacement
    Standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass
    Interventions:
    • Dietary Supplement: Herbalife Meal Replacements
    • Dietary Supplement: Herbalife Meal Replacements
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 30 years and older at screening
  2. 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.
  3. BMI of 27 to 40 kg/m2 inclusive.
  4. 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.

Exclusion Criteria:

  1. Weight Stability. Any subject who reports weight change of > 3.0 kg in the month prior to screening.
  2. 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.
  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 > 500 mg/dl, total cholesterol > 350 mg/dl, TSH outside of normal range.
  5. Subjects who drink more than 1 alcoholic beverages per day.
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030354
UCLA OPRS 03-06-120
No
Zhaoping Li, MD, PhD, Professor of Medicine, UCLA Center for Human Nutrition
University of California, Los Angeles
  • National Institutes of Health (NIH)
  • Herbalife, International, Los Angeles, California
Principal Investigator: Zhaoping Li, MD, PhD University of California, Los Angeles
University of California, Los Angeles
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP