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Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis

Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis indicators in bariatric surgery candidates: a randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231116060076N1
Enrollment
110
Registered
2023-11-30
Start date
2023-12-11
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome, liver fibrosis and steatosis. Metabolic syndrome, Hepatic fibrosis, Hepatic steatosis,

Interventions

Intervention 1: Intervention group: includes 55 morbidly obese patients who are candidates for bariatric surgery and who meet the study entry criteria, who will be given a daily supplement containing

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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 physician based on biochemical and clinical analyses Diagnosis of metabolically dysfunction–associated fatty liver disease (MASLD) through ultrasound, biochemical and clinical analyses by a specialist physician Willingness to cooperate in the project No known allergies to curcumin or turmeric

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Fasting plasma glucose. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay.;2. Triglyceride. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay.;High Density Lipoprotein (HDL). Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay.;Blood Pressure. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Mercury sphygmomanometer.;Anthropometric measurements. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Height will be measured without shoes, with an accuracy of 0.5 cm, using a caliper. Weight, BMI, and waist-to-hip ratio will be measured using a bioelectrical impedance analyzer.;Degree of hepatic steatosis or fibrosis. Timepoint: Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Liver elastography will be performed before the intervention and 6 months after surgery. Also, a liver biopsy will be performed at the end of the intervention (during surgery).

Secondary

MeasureTime frame
Liver enzymes (ALT, AST, ALP). Timepoint: All variables will be measured at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: Blood test using a laboratory assay.;Checking insulin resistance based on the HOMA-IR formula. Timepoint: All variables will be measured at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery. Method of measurement: It will be measured by collecting a fasting blood sample at any time point and measuring fasting blood insulin and glucose levels using the formula HOMA-IR = [Fasting Glucose (mg/dL) x Fasting Insulin (mU/L)] / 405.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohadeseh Hassan zadeh

Mashhad University of Medical Sciences

hasanzadehm4001@mums.ac.ir+98 51 3882 7034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026