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

Primary Purpose

Weight Reduction, Obesity, Weight Management

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Herbalife Meal Replacements

About this trial

This is an interventional treatment trial for Weight Reduction focused on measuring Satiety, Meal Replacements, High Protein, Standard Protein

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Dietary Intervention and Higher protein meal replacement

Dietary Intervention and Standard Protein Meal Replacement

Arm Description

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

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

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is the change in weight.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01030354

First Posted

December 10, 2009

Last Updated

December 10, 2009

Sponsor

University of California, Los Angeles

Collaborators

National Institutes of Health (NIH), Herbalife International of America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01030354

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

July 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, Los Angeles

Collaborators

National Institutes of Health (NIH), Herbalife International of America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Reduction, Obesity, Weight Management

Keywords

Satiety, Meal Replacements, High Protein, Standard Protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary Intervention and Higher protein meal replacement

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dietary Intervention and Standard Protein Meal Replacement

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Herbalife Meal Replacements

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Herbalife Meal Replacements

Intervention Description

Primary Outcome Measure Information:

Title

The primary efficacy endpoint is the change in weight.

Time Frame

Baseline, 3, 6 and 12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li, MD, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21194471

Citation

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.

Results Reference

derived

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

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