Gastrointestinal Hormonal Regulation of Obesity (NCT01146704) | Clinical Trial Compass
CompletedNot Applicable
Gastrointestinal Hormonal Regulation of Obesity
United States31 participantsStarted 2010-09-01
Plain-language summary
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For inclusion in the study, patients must fulfill all of the following criteria:
* Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit.
* Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
* Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:
* Age 30 years and older at screening.
* BMI of 27 to 40 kg/m2 inclusive.
* Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC.
* 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.
* Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable.
* Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comp…
What they're measuring
1
Change in Body Weight From Baseline to 12 Months
Timeframe: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.