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.
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.
Design
A controlled, parallel-group, triple-blind, randomized, phase 4 clinical trial on 110 patients. For randomization, special randomization sites such as sealed envelope are used.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Willingness to cooperate in the project and not suffering from different allergies
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
Intervention groups
Patients with morbid obesity referred to the bariatric surgery clinic and met the inclusion criteria
Main outcome variables
The amount of changes in metabolic syndrome indicators:
anthropometric analysis (weight and waist circumference), biochemical analysis (CBC, FBS, HbA1c, Insulin, HOMA-IR, TG, Total Cholesterol, LDL, HDL), systolic and diastolic blood pressure, liver elastography and liver tissue biopsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231116060076N1
Registration date:2023-11-30, 1402/09/09
Registration timing:prospective
Last update:2023-11-30, 1402/09/09
Update count:2
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Mohadeseh Hassan zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 7034
Email address
hasanzadehm4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Investigating the therapeutic effect of curcumin-peperin supplementation on metabolic syndrome, and liver fibrosis and steatosis
Purpose
Treatment
Inclusion/Exclusion 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 doctor based on biochemical and clinical analyses
Willingness to cooperate in the project
No allergies
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qureshi Building, University Street, Mashhad, Khorasan Razavi
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 outcomes
1
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient bariatric surgery clinic of Imam Reza Hospital
Full name of responsible person
Reza Rezvani
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۷۶۳۵۵۶۷
Phone
+98 51 3802 2000
Email
Hasanzadehm4001@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
City
M,ashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
mds.nutrition@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadeseh Hassan zadeh
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
hasanzadehm4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
RezvaniR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadeseh Hassan zadeh
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
hasanzadehm4001@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available