Text Size

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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
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
  Purpose

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).


Condition Intervention Phase
Weight Reduction
Obesity
Weight Management
 Dietary Supplement: Herbalife Meal Replacements
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change in weight. [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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 Standard Protein Meal Replacement
Standard protein meal replacement diet based on ½ gram of protein per pound of lean body mass
 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030354

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Herbalife, International, Los Angeles, California
Investigators
Principal Investigator: Zhaoping Li, MD, PhD University of California, Los Angeles
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zhaoping Li, MD, PhD, Professor of Medicine, UCLA Center for Human Nutrition
ClinicalTrials.gov Identifier: NCT01030354     History of Changes
Other Study ID Numbers: UCLA OPRS 03-06-120
Study First Received: December 10, 2009
Last Updated: December 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Satiety
Meal Replacements
High Protein
Standard Protein

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013