Protocol summary

Study aim
The effect of Wheat Germ consumption on anthropometric indices, lipid profiles, glycemic status, hepatic enzymes, hepatocyte apoptosis (Cytokeratin-18), inflammatory factors, total antioxidant capacity and liver fibrosis in non-alcoholic fatty liver patients
Design
Randomized clinical trials with control groups, parallel group are performed on 42 patients
Settings and conduct
In this study, adults with non-alcoholic fatty liver disease referred to liver clinic of Taleghani hospital, who have the criteria to enter the study, if they desire to participate in this research fill out general and activity questionnaires and anthropometric indicators are collected. At the beginning and end of the study, fibroscan and blood tests are performed to evaluate the indicators
Participants/Inclusion and exclusion criteria
People who desire to participate in the study; age 18-50 years; BMI above 25 who have evidence of non-alcoholic steatohepatitis in ultrasound or fibroscan; no history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men; absence of other chronic and acute liver diseases and disorders, biliary tract disease, autoimmune diseases, cancer and hereditary disorders affecting Liver status and liver cirrhosis, lack of pregnancy or lactation in women; no use of hepatotoxic drugs are included in the study. If they do not want to continue studying or using hepatotoxic drugs during the study or non-compliance with the diet, they are excluded.
Intervention groups
1- Control 2-wheat germ
Main outcome variables
Hepatic fibrosis, and steatosis Lipid profile, Glycemic indices, Liver enzymes, Inflammatory factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004010N32
Registration date: 2020-11-07, 1399/08/17
Registration timing: prospective

Last update: 2020-11-07, 1399/08/17
Update count: 0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Wheat Germ consumption on anthropometric indices, lipid profiles, glycemic status, hepatic enzymes, hepatocyte apoptosis (Cytokeratin-18), inflammatory factors, total antioxidant capacity and liver fibrosis in non-alcoholic fatty liver patients
Public title
The effect of Wheat Germ consumption on anthropometric indices, lipid profiles, glycemic status, hepatic enzymes, hepatocyte apoptosis, inflammatory factors, total antioxidant capacity and liver fibrosis in non-alcoholic fatty liver patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General desire to participate in the study Age 50-30 years Has evidence of non-alcoholic steatohepatitis and CAP score more than 263 Body mass index (BMI) ≥ 25kg / m2 No history of alcohol consumption Lack of other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseases and hereditary disorders affecting the condition of the liver (iron, copper and ... ) No pregnancy or breastfeeding in women Do not take hepatotoxic drugs such as phenytoin, amoxifen and lithium Do not take antibiotics for more than a week during or before the study period Do not consume Milk thistle(Silybum marianum) Lack of chronic inflammatory disease No history of cancer Lack of treatment with anti-inflammatory drugs Lack of recent weight loss diet Do not use weight loss drugs (chemical drugs and effective herbal products)
Exclusion criteria:
Changes in medications (lipid-lowering drugs, blood sugar control drugs, and blood pressure medications) during the study period Lack of adherence to the intervention given to patients Take supplements or substances that change the individual effect during the intervention
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The first step is to create a random sequence number. For this purpose, we will use a random number generator on Stattrek (https://stattrek.com/statistics/random-number-generator.aspx) for 50 numbers range from 1 to 2 (for example: 2 1 1 1 2 1 2 1 1 2 2 1 1 2 2 2 2 11 1 2 2 1 1 1 2 2..............).Then, we will specify the numbers to the groups for example, 1 will be assigned to the intervention group one (wheat germ), the numbers 2 to the control group. Each number will represent a group according to the defined numbers. With this method, we will have a specific sequence of 50 codes of 1, 2 , which shows the first to fifty people who are going to be entered in the study in each group. We write the codes on a piece of paper and put them in an envelope to use during sampling. Thus, after reviewing the inclusion criteria and if the participants desire, we will enter each person included in the study according to our predetermined list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the National Institute of Nutritional Research and Food Industry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1399.045

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)

Primary outcomes

1

Description
Hepatic steatosis, Liver fibrosis
Timepoint
At the first and at the 12th week of the study
Method of measurement
fibroscan

Secondary outcomes

1

Description
Weight
Timepoint
At the first and 12th week of the study
Method of measurement
Scale

2

Description
BMI
Timepoint
At the first and 12th week of the study
Method of measurement
Calculate

3

Description
liver enzymes (AST,ALT,GGT)
Timepoint
At the first and 12th week of the study
Method of measurement
Enzymatic method

4

Description
lipid profile (TG,Total cholesterol,LDL-C,HDL-C)
Timepoint
At the first and 12th week of the study
Method of measurement
Enzymatic method

5

Description
hs-CRP
Timepoint
At the first and 12th week of the study
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: wheat germ
Category
Lifestyle

2

Description
Control group: bread crumbs
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Liver Clinic of Taleghani Hospita
Full name of responsible person
Azita Hekmatdoost
Street address
Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2235 7484
Email
a_hekmat2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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