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Completed

NCT Number: NCT02908152

Curcumin Supplement 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NNFTRI

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curcumin

Dietary Supplement

1500 mg

1 capsule / day for 12 weeks

Placebo

Dietary Supplement

1500 mg

1 capsule / day for 12 weeks

Primary outcomes

  1. Hepatic steatosis

    Time frame: [12 weeks]

    measured by CAP score using Fibroscan

Secondary outcomes

  1. Glucose

    Time frame: [12 weeks]

  2. HBA1C

    Time frame: [12 weeks]

  3. ALT

    Time frame: [12 weeks]

  4. AST

    Time frame: [12 weeks]

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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