Curcumin Supplement in Nonalcoholic Fatty Liver Patients

Phase 2

Completed

• Conditions: Nonalcoholic Fatty Liver; Type 2 Diabetes
• Interventions: Dietary Supplement: curcumin; Dietary Supplement: placebo

• Registration Number: NCT02908152
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Study Start: 2017-02-10
• Primary Completion: 2017-07-10
• Study Completion: 2017-10-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-26
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
curcumin	curcumin	curcumin
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Hepatic steatosis	[12 weeks]	measured by CAP score using Fibroscan

Secondary Outcome Measures

Name	Time	Method
Glucose	[12 weeks]
HBA1C	[12 weeks]
AST	[12 weeks]
ALT	[12 weeks]

Trial Locations

Locations (1)

NNFTRI; 🇮🇷 Tehran, Iran, Islamic Republic of