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Curcumin Supplement in Nonalcoholic Fatty Liver Patients

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02908152
Enrollment
50
Registered
2016-09-20
Start date
2017-02-10
Completion date
2017-10-10
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Fatty Liver, Type 2 Diabetes

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.

Interventions

DIETARY_SUPPLEMENTcurcumin

1500 mg 1 capsule / day for 12 weeks

DIETARY_SUPPLEMENTplacebo

1500 mg 1 capsule / day for 12 weeks

Sponsors

National Nutrition and Food Technology Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hepatic steatosis[12 weeks]measured by CAP score using Fibroscan

Secondary

MeasureTime frame
Glucose[12 weeks]
HBA1C[12 weeks]
ALT[12 weeks]
AST[12 weeks]

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026