Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, Los Angeles
With
National Institutes of Health (NIH)
Herbalife International of America, Inc.
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.
Age
30–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial
