Protocol summary

Summary
This study ‎as a double-blind randomised controlled trial will be conducted in 84 overweight or obese patients ‎with non-alcoholic fatty liver. Disease is diagnosed using ‎ultrasonography by a radiologists. Patients are divided into nanocurcumin and placebo ‎supplementation equal groups (ratio 1:1). The period of study is considered three months. Two ‎‎40mg capsules (nanocurcumin or placebo) will be included daily with breakfast and dinner meals. ‎Advises of lifestyle changes include low-calorie diet and increasing physical activity. Food intakes, ‎physical activity, weight, height, blood pressure and body composition of patients are measured at ‎different visits. At the beginning and end of the study 10 ml blood from the brachial vein of ‎patients will be taken to measure serum levels of liver enzymes (Alanin transaminase (ALT), Aspartate transaminase (AST)), fasting glucose (FBS) and ‎insulin (FBI)), Hemoglobin A1C (HbA1C), lipid profile (Low Density Lipoprotein-Cholestrol (LDL) , High Density Lipoprotein-Cholestrol (HDL), Triglyceride (TG), Total Cholestrol (TC)), Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), high sensitive-C-Reactive Protein (hs-CRP) and nesfatin. Also, insulin ‎indexes (Homeostatic model assessment-insulin resistance (HOMA-IR), Quantitative insulin sensitivity check index (QUICKI)) are calculated by the following formula:‎ QUICKI = 1 / (log (fasting insulin μU / mL) + log (fasting glucose mg / dL))‎ HOMA-IR = (FPI (mU / l) x FPG (mmol / l)) / 22.5‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071915536N3
Registration date: 2016-08-02, 1395/05/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The clinical trial of effects of nanocurcumin supplementation on blood nesfatin, insulin resistance indexes, lipids and inflammatory factors in overweight and obese patients with non-alcoholic fatty liver disease ‎‎(NAFLD)‎
Public title
Effects of nanocurcumin in the treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:‎ Non-alcohilic fatty liver disease diagnosed by a radiologist and hepatologist using ‎ultrasonography into one of three categories (mild, moderate or severe degree); Age 25–50 years; Overwight or obesity (25≤BMI<35). Exclusion Criteria:‎ History of alcohol consumption at the time of the study or in the past 12 months, based on ‎patient confession; Diagnosed pathological conditions affecting the liver such as viral hepatitis, acute or chronic ‎liver failure, cholestasis, liver transplantation, habitual abuse of nonsteroidal anti-inflammatory ‎drugs, antibiotics, anti-secretory drugs cause achlorhydria within 3 months before the study, ‎Corticosteroids, amiodarone, valproate, prednisone, tamoxifen, perhexiline and methotrexate, ‎rapid weight loss, diabetes, heart failure, thyroid disorders, kidney disease, respiratory failure, ‎psychological disorders, hereditary hemochromatosis and Wilson disease, alpha-1 antitrypsin ‎deficiency, autoimmune diseases, celiac disease, use of liver fat inducer and hormonal drugs; Acute systemic disease, cystic fibrosis disease, muscular dystrophy, protein malnutrition, ‎history of gastrointestinal surgery, neurological disorders, structural abnormalities of the ‎gastrointestinal tract; The secondary causes of NAFLD, including drugs, surgical procedures, environmental toxins ‎and total parenteral nutrition (TPN)‎; Conditions lead to the physical inactivity (disability)‎; Uncontrolled hypertension (>90/140 mmHg)‎; Any diagnosed malignancy; Breast-feeding, pregnancy and or plan for pregnancy in the next 3 months; Professional athlete or regular exercise; Treatment with statins, antihypertensive and ursodeoxy colic acid, probiotics and ‎multivitamin-mineral and antioxidant supplements during the three months prior to the ‎intervention; Surgery for weight loss in the last year and weight loss program for the past three month; Taking a multivitamin-mineral and or antioxidants supplement at least once a week during the ‎study; Not taking more than 10% of prescription supplements‎
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No.1, Qods Ave, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.TUMS.REC.1395.2612

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K75.8, K76
ICD-10 code description
Nonalcoholic steatohepatitis, Nonalcoholic fatty liver disease

Primary outcomes

1

Description
Nesfatin
Timepoint
At the beginning and end of intervention
Method of measurement
serum levels (ng/ml‎) by Elisa

Secondary outcomes

1

Description
ALT/AST/TG/TC/HDL/LDL/FBS/FBI/HbA1C/TNF-Alpha/IL-6/hs-CRP
Timepoint
At the beginning and end of intervention
Method of measurement
Serum levels by Elisa

2

Description
Blood pressure, Body composition, Body Mass Iindex, Waist Circumference
Timepoint
At the beginning and end of intervention
Method of measurement
Mercury manometer, BIA, Formula, Tape measure (mmhg, %, kg/m2, cm), respectively

Intervention groups

1

Description
Intervention Group: Nanocurcumin supplementation with dose of 80mg (40mg bid with breakfast and dinner meals) for 3 months.
Category
Treatment - Other

2

Description
Placebo Group: Placebo supplementation with dose of 80mg (40mg bid with breakfast and dinner meals) for 3 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital of Oil Company
Full name of responsible person
Siavash Mansouri
Street address
No.11, Sakhaei Ave, Hafez St, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Javad Hosseinzadeh-Attar
Street address
No.44, Hojjatdoust Alley, Naderi St, Keshavarz Blvd, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences‎
Full name of responsible person
Mohammad-Javad Hosseinzadeh-Attar
Position
MD, PhD, Associate Professor
Other areas of specialty/work
Street address
No.44, Hojjatdoust Alley, Naderi Ave, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
mhosseinzadeh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences‎
Full name of responsible person
Mohammad-Javad Hosseinzadeh-Attar
Position
MD, PhD, Associate Professor
Other areas of specialty/work
Street address
No.44, Hojjatdoust Alley, Naderi Ave, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
mhosseinzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Javad Hosseinzadeh-Attar
Position
MD, PhD, Associate Professor
Other areas of specialty/work
Street address
No.44, Hojjatdoust Alley, Naderi Ave, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
mhosseinzadeh@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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