1. Home
  2. Approved trials
  3. » فارسی

The effect of oat consumption on hepatic and blood glucose control indices and lipid profile in patients with non-alcoholic fatty liver

Protocol summary

Study aim
assessing changes in fasting blood sugar, insulin, total cholesterol, LDL, HDL, triglycerides, alanine aminotransferase, aspartate aminotransferase, Homeostasis Model Assessment Insulin Resistance (HOMA-IR), and Quantitative Insulin Sensitivity Check Index (QUICKI) after 90 days Oat consumption and adherence to diet in the intervention group compared to the control group.
Design
A parallel-group, open-label, randomized controlled clinical trial of 80 patients. Randomized with stratified randomization based on BMI
Settings and conduct
People referring to a gastroenterology office, and receiving study information, were included in the study. After measuring the height and weight and completing the questionnaires, After blood sampling the diet and if they are in the intervention group, they will receive oats for 6 weeks. In the sixth week, they return to the clinic to receive oats (intervention group), measure their weight, and deliver food records. The study ends in the twelfth week after blood sampling and reweighing. The people who check the blood samples are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: fatty liver patients over 18 years, liver enzyme between normal up to 2 times the average level, not alcohol consumption, not pregnant and breastfeeding, not suffering from cirrhosis, not following a diet, not Having malignancy and underlying disease, not using insulin, BMI between 25-40 kg/m² Exclusion criteria: unwillingness to consume oats, change in medications.
Intervention groups
The intervention group consumes 50 grams of oats twice a day and follows a diet. In contrast, the control group only follows a diet according to their weight and physical activity.
Main outcome variables
changes in fasting blood sugar, insulin, total cholesterol, LDL, HDL, triglycerides, alanine aminotransferase, aspartate aminotransferase, HOMA-IR, and QUICKI index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130903014551N12
Registration date: 2023-01-18, 1401/10/28
Registration timing: prospective

Last update: 2023-01-18, 1401/10/28
Update count: 0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oat consumption on hepatic and blood glucose control indices and lipid profile in patients with non-alcoholic fatty liver
Public title
Effect of Oat in patients with Non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 2,3,4 non alcoholic fatty liver disease by ultrasound The level of liver enzymes should be between normal up to 2 times than average level A person should not consume alcohol or use less than 30 grams for men and 20 grams for women Absence of pregnancy and breastfeeding Absence of liver cirrhosis Not following a special diet Absence of malignancy and underlying diseases Not taking insulin in diabetic patients BMI should be between 25-40 kg/m²
Exclusion criteria:
Reluctance to consume oats Starting a new drug or changing the dose of previous drugs related to fatty liver in the last two months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
People with NAFLD are equally divided into 2 intervention and control groups. By stratified randomization based on BMI (between 25 and 30 and greater than and equal to 30), people are placed in 2 intervention and control groups. Individuals are matched between intervention and control groups based on BMI.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-01-16, 1401/10/26
Ethics committee reference number
IR.ARI.MUI.REC.1401.260

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Nonalcoholic fatty liver disease

Primary outcomes

1

Description
Alanine amino transferase (ALT)
Timepoint
Measuring alanine aminotransferase before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

2

Description
aspartate aminotransferase
Timepoint
Measuring aspartate aminotransferase before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

3

Description
fasting blood glucose (FBS)
Timepoint
Measuring fasting blood glucose before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

4

Description
Insulin
Timepoint
Measuring Insulin before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

5

Description
Total Cholesterol
Timepoint
Measuring total Cholesterol before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

6

Description
Low density lipoprotein (LDL)
Timepoint
Measuring LDL before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

7

Description
High density lipoprotein (HDL)
Timepoint
Measuring HDL before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

8

Description
Triglyceride (TG)
Timepoint
Measuring TG before the intervention and At the end of the twelfth week
Method of measurement
Blood sample and autoanalyzer

9

Description
Quantitative Insulin Sensitivity Check Index (QUICKI)
Timepoint
Measuring(QUICKI) before the intervention and At the end of the twelfth week
Method of measurement
QUIKI = 1 / [log fasting insulin (FI) + log fasting glucose (FG)]

10

Description
Homeostasis Model Assessment Insulin Resistance (HOMA-IR)
Timepoint
Measuring (HOMA-IR) before the intervention and At the end of the twelfth week
Method of measurement
HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 12 weeks, 50 grams of oat powder should be consumed twice a day (25 grams) with 1 glass of water, milk, and dough. The time to consume oats is morning and evening between meals. Oat powder was prepared by Pakan Bazr Company. Also, people use a diet according to their BMI and physical activity. In order to adjust the diet for each person, the basic energy is calculated based on the Mifflin-St formula. Adjusted Ideal Body Weight (AIBW) is used to calculate a person's energy needs. In the prescribed diet, 50-55% of calories come from carbohydrates, 15-20% of calories come from protein, and 25-30% come from fat.
Category
Treatment - Other

2

Description
Control group: For 12 weeks, people use a diet according to their BMI and physical activity. In order to adjust the diet for each person, the basic energy is calculated based on the Mifflin-St formula. Adjusted Ideal Body Weight (AIBW) is used to calculate a person's energy needs. In the prescribed diet, 50-55% of calories come from carbohydrates, 15-20% of calories come from protein, and 25-30% come from fat.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Amrollah Ebrahimi' s office
Full name of responsible person
Dr. Amrollah Ebrahimi
Street address
4th floor, Razi complex, Shams Abadi street, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8134776539
Phone
+98 993 181 4461
Email
a_ev11@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Deputy of Research & Technology of Isfahan University of Medical Science, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 8487
Email
Askari@mui.ac.ir
Web page address
https://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Fax
+98 31 1668 2509
Email
s_m_rouhani2003@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Fax
+98 31 1668 2509
Email
s_m_rouhani2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Fax
+98 31 1668 2509
Email
s_m_rouhani2003@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
Loading...