Curcumin Supplement in Nonalcoholic Fatty Liver Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908152
• Other study ID #: 467
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 10, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: September 2020
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Type 2 Diabetes

Intervention

Dietary Supplement:
• curcumin
1500 mg 1 capsule / day for 12 weeks
• placebo
1500 mg 1 capsule / day for 12 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	NNFTRI	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic steatosis	measured by CAP score using Fibroscan	[12 weeks]
Secondary	Glucose		[12 weeks]
Secondary	HBA1C		[12 weeks]
Secondary	ALT		[12 weeks]
Secondary	AST		[12 weeks]