Protocol summary
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Study aim
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Determining the therapeutic effects of curcumin-piperine supplementation on the indicators of metabolic syndrome, and liver fibrosis and steatosis in patients who are candidates for bariatric surgery.
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Design
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A controlled, parallel-group, triple-blind, randomized, phase 2 clinical trial on 110 patients. For randomization, special randomization sites such as sealed envelope are used.
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Settings and conduct
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A three-way blind controlled study will be conducted on bariatric surgery candidates with inclusion criteria, by giving a capsule containing 500 mg of curcumin and 5 mg of peprine to the intervention group and a placebo to the control group, for 8 weeks.
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Participants/Inclusion and exclusion criteria
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Patients with morbid obesity referred to the bariatric surgery clinic and met the inclusion criteria
Entry requirements
- Patients with morbid obesity and candidates for bariatric surgery in the age range of 18 to 65 years
- Diagnosis of metabolic syndrome based on tests
-Diagnosis of metabolically dysfunction-associated fatty liver disease (MASLD) through ultrasound, biochemical and clinical analyses
Willingness to cooperate in the project and No allergy to curcumin or turmeric
Non-entry conditions
- Regular consumption of multivitamin-mineral supplements and consumption of herbal extracts such as silymarin during the last 3 months
- Diagnosed pathological conditions effective on the body
- History of gastrointestinal diseases, autoimmunity and various malignancies
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Intervention groups
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Patients with morbid obesity referred to the bariatric surgery clinic and met the inclusion criteria
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Main outcome variables
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The amount of changes in metabolic syndrome indicators:
anthropometric analysis, biochemical analysis (FBS, HbA1c, Insulin, TG, LDL, HDL), systolic and diastolic blood pressure and Examining changes in the degree of hepatic steatosis or fibrosis
General information
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Reason for update
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Following approval of the changes to the proposal by the Research Committee of the Clinical Nutrition Department of Mashhad University of Medical Sciences, this update was made based on the amendment to the proposal.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231116060076N1
Registration date:
2023-11-30, 1402/09/09
Registration timing:
prospective
Last update:
2025-06-01, 1404/03/11
Update count:
2
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Registration date
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2023-11-30, 1402/09/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-11, 1402/09/20
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Expected recruitment end date
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2024-09-21, 1403/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization with blocks of 4 and 6 will be done using special randomization sites such as sealed envelopes. After specifying the codes, each code is written separately on a sheet. Each sheet is placed in a separate envelope or folded and glued in such a way that it cannot be seen inside (allocation concealment). After obtaining informed consent, a sheet will be removed from each qualified patient and according to the code written in it, people will be placed in two study groups.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The patient receives the drug (intervention or control group) in sealed envelopes that are coded. Coding is done by one of the collaborators of the project and the patient, researcher and analyst are blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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In this study, food intake using a 24-hour food recall questionnaire and physical activity using the international IPAQ questionnaire will be examined as confounding variables before the intervention and 6 months after surgery.
Ethics committees
1
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Ethics committee
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Approval date
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2023-09-23, 1402/07/01
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1402.318
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome, liver fibrosis and steatosis
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ICD-10 code
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E88.8, K74
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ICD-10 code description
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Metabolic syndrome, Hepatic fibrosis, Hepatic steatosis,
Primary outcomes
1
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Description
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Fasting plasma glucose
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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Blood test using a laboratory assay
2
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Description
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2. Triglyceride
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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Blood test using a laboratory assay
3
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Description
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High Density Lipoprotein (HDL)
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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Blood test using a laboratory assay
4
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Description
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Blood Pressure
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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Mercury sphygmomanometer
5
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Description
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Anthropometric measurements
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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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.
6
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Description
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Degree of hepatic steatosis or fibrosis
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Timepoint
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Measurements will be taken at the beginning of the study (before the intervention), at the end of the intervention, and 6 months after surgery.
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Method of measurement
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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 outcomes
1
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Description
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Liver enzymes (ALT, AST, ALP)
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Timepoint
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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.
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Method of measurement
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Blood test using a laboratory assay
2
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Description
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Checking insulin resistance based on the HOMA-IR formula
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Timepoint
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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.
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Method of measurement
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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.
Intervention groups
1
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Description
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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 500 mg of curcumin and 5 mg of peprine for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: It includes 55 patients with morbid obesity and candidates for bariatric surgery who meet the inclusion criteria and will be given a placebo daily for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available