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Curcumin Supplement in Nonalcoholic Fatty Liver Patients

Primary Purpose

Type 2 Diabetes, Nonalcoholic Fatty Liver

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
curcumin
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NNFTRI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

curcumin

placebo

Arm Description

curcumin

Outcomes

Primary Outcome Measures

Hepatic steatosis
measured by CAP score using Fibroscan

Secondary Outcome Measures

Glucose
HBA1C
ALT
AST

Full Information

First Posted
September 5, 2016
Last Updated
September 26, 2020
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02908152
Brief Title
Curcumin Supplement in Nonalcoholic Fatty Liver Patients
Official Title
The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Nonalcoholic Fatty Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
curcumin
Arm Type
Active Comparator
Arm Description
curcumin
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin
Intervention Description
1500 mg 1 capsule / day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
1500 mg 1 capsule / day for 12 weeks
Primary Outcome Measure Information:
Title
Hepatic steatosis
Description
measured by CAP score using Fibroscan
Time Frame
[12 weeks]
Secondary Outcome Measure Information:
Title
Glucose
Time Frame
[12 weeks]
Title
HBA1C
Time Frame
[12 weeks]
Title
ALT
Time Frame
[12 weeks]
Title
AST
Time Frame
[12 weeks]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
NNFTRI
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Curcumin Supplement in Nonalcoholic Fatty Liver Patients

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