Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis
- Conditions
- Metabolic syndrome, liver fibrosis and steatosis.Metabolic syndrome, Hepatic fibrosis, Hepatic steatosis,E88.8, K74
- Registration Number
- IRCT20231116060076N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Patients with morbid obesity and candidates for bariatric surgery in the age range of 18 to 65 years
Diagnosis of metabolic syndrome by a specialist doctor based on biochemical and clinical analyses
Willingness to cooperate in the project
No allergies
Regular consumption of multivitamin-mineral supplements, antioxidants, and omega-3 supplements in amounts exceeding the daily requirement, probiotic supplements, and consumption of herbal extracts such as silymarin during the past 3 months.
Diagnosed pathological conditions affecting the liver such as types of viral hepatitis and liver transplantation
History of gastrointestinal diseases, organ failure, thyroid disorders, kidney diseases, autoimmune diseases, severe mental diseases and types of malignancy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting plasma glucose more than 126, triglyceride more than 199, blood pressure more than 140/90, High Density Lipoprotein (HDL) less than 40, Degree of Hepatic steatosis and fibrosis. Timepoint: All variables will be measured at the beginning of the study (before the start of the intervention), at the end of the intervention (8 weeks after the start of the intervention and before surgery) and 6 months after the surgery. Method of measurement: Biochemical variables such as fasting plasma glucose, triglycerides, and high-density lipoprotein (HDL) will be measured by collecting fasting blood samples at each time point, and blood pressure will be measured using a mercury sphygmomanometer. In order to determine the degree of liver fibrosis and steatosis, elastography will be performed at any time. Also, a biopsy of the liver tissue is performed during surgery.
- Secondary Outcome Measures
Name Time Method The amount of physical activity, the amount of Dietary intake, detailed examination of fat tissue changes, examination of liver enzymes (ALT, AST, ALP). Timepoint: All variables will be measured at the beginning of the study (before the start of the intervention), at the end of the intervention (8 weeks after the start of the intervention and before surgery) and 6 months after the surgery. Method of measurement: The amount of physical activity will be done using the International Physical Activity Questionnaire (IPAQ) and the amount of food intake will be done using the 24-hour 3-day food recall questionnaire. Fat tissue changes will be done using a body composition analysis device, and a fat tissue biopsy will be taken from the patient during the operation. Also, to check liver enzymes, blood samples are taken from patients at each follow-up appointment.