Curcumin Supplement in Nonalcoholic Fatty Liver Patients

NCT ID: NCT02908152

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2017-10-10

Brief Summary

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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

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Conditions

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Type 2 Diabetes Nonalcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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curcumin

curcumin

Group Type ACTIVE_COMPARATOR

curcumin

Intervention Type DIETARY_SUPPLEMENT

1500 mg

1 capsule / day for 12 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

1500 mg

1 capsule / day for 12 weeks

Interventions

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curcumin

1500 mg

1 capsule / day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

1500 mg

1 capsule / day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NNFTRI

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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467

Identifier Type: -

Identifier Source: org_study_id

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