Curcumin Supplement in Nonalcoholic Fatty Liver Patients

NCT02908152 | Completed Phase 2 DMC

• 1 other identifier: 467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

• Hepatic steatosis

  measured by CAP score using Fibroscan

  [12 weeks]

Secondary Outcomes (4)

• Glucose

  [12 weeks]

• HBA1C

  [12 weeks]

• ALT

  [12 weeks]

• AST

  [12 weeks]

Study Arms (2)

curcumin

ACTIVE COMPARATOR

curcumin

Dietary Supplement: curcumin

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

curcumin DIETARY_SUPPLEMENT

1500 mg 1 capsule / day for 12 weeks

curcumin

placebo DIETARY_SUPPLEMENT

1500 mg 1 capsule / day for 12 weeks

placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

NNFTRI

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 20, 2016
• Study Start: February 10, 2017
• Primary Completion: July 10, 2017
• Study Completion: October 10, 2017
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

IR (1)