- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030354
Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
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.
|
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
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy endpoint is the change in weight.
Time Frame: Baseline, 3, 6 and 12 months
|
Baseline, 3, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline and 12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCLA OPRS 03-06-120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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