Curcumin Supplement in Nonalcoholic Fatty Liver Patients

The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients

The purpose of this study is to investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Nonalcoholic Fatty Liver
• Intervention / Treatment: Dietary supplement: curcumin; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • NNFTRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug;
• CAP score >263.

Exclusion Criteria:

• Taking any kind of antibiotics two weeks before recruitment;
• History of alcohol consumption;
• pregnancy or lactation;
• Professional athletes;
• Other liver disease (viral/etc);
• High dose synthetic estrogens, methotrexate, amiodarone, steroids, chloroquine, immunosuppressive drugs;
• A history of Cardiovascular disease;
• Renal disease, Celiac disease, Cirrhosis;
• History of Upper GI surgery;
• A history of hypothyroidism or Cushing's syndrome;
• History of drug dependence;
• Body mass index (BMI) ≥35 kg/m2;
• A restrictive diet or weight change ≥ 5 kg during the 3months prior to study;
• Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
• Use of weight loss medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo; 1500 mg 1 capsule / day for 12 weeks
Active Comparator: curcumin	Dietary supplement: curcumin; 1500 mg 1 capsule / day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic steatosis	measured by CAP score using Fibroscan	[12 weeks]

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucose	[12 weeks]
HBA1C	[12 weeks]
ALT	[12 weeks]
AST	[12 weeks]

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 26, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 467

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No