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The effects of intermittent fasting diet in comparison with low calorie diet on lipid profile, glycemic status and liver fibrosis in patients with non-alcoholic fatty liver

Protocol summary

Study aim
The effect of intermittent fasting diet in comparison with low calorie diet on lipid, glycemic and fibrosis parameters in patients with non-alcoholic fatty liver
Design
The present study will be a parallel clinical trial in which all people who are eligible to enter the study and volunteer to participate in the study will be given sufficient information about the objectives of the study, the type of intervention and the duration of the study. Prior to the intervention, individuals will be grouping based on body mass index (25-30 / 30-35) and gender (female / male). The genders will be matched.
Settings and conduct
Patients are randomly selected from those referred to Masoud Clinic in Tehran. The regimen delivered to patients in the control and intervention groups will be monitored for 12 weeks. At the beginning and end of the study, the main outcome variables are measured and compared to determine the effect of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1) Age 50-20 years 2) Diagnosis of steatohepatitis based on cap-score> 263 3) People with hepatic fibrosis based on metavir-score ≤ F2 exclusion criteria : 1) Other acute and chronic liver diseases, autoimmune diseases, kidney diseases, biliary diseases, diabetes, cancer 2) use of hepatotoxic drugs
Intervention groups
In the intervention group, an intermittent fasting diet of the type (16: 8) will be used, in which individuals are allowed to receive only water and non-energy drinks for 16 hours (from 8 pm to 12 am the next day). Tea, coffee, and sugar-free chewing gum are free to eat for 8 hours (from 12 noon to 8 pm). People in the control group also receive a low-calorie diet, which ultimately reduces the total calculated energy by 300 kcal.
Main outcome variables
Blood sugar measurement, lipid profile and liver fibrosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170202032367N5
Registration date: 2022-03-05, 1400/12/14
Registration timing: prospective

Last update: 2022-03-05, 1400/12/14
Update count: 0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Hossien Imani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
h-imani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intermittent fasting diet in comparison with low calorie diet on lipid profile, glycemic status and liver fibrosis in patients with non-alcoholic fatty liver
Public title
The effect of intermittent fasting diet on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50-20 years Body mass index 25 - 30 kg/m2 Both genders Diagnosis of osteohepatitis based on Cap-score> 263 subjects with hepatic fibrosis based on Metavir-score ≤ F2 Willingness to cooperate
Exclusion criteria:
Consumption of alcohol Other acute and chronic liver diseases Autoimmune diseases, kidney diseases, biliary diseases, diabetes, cancer Pregnancy and lactation Use of hepatotoxic drugs (phenytoin, lithium, tamoxifen, antibiotics), weight loss drugs, sage and corticosteroids Follow a special diet in the last three months
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization method is used for randomization. In this method, eligible individuals with inclusion criteria are selected and then they are randomly selected using 4 blocks that block based on BMI (greater than 30 and between 25 and 30) and age (20-35 and 35-40 years old) will be assigned to one of the two groups of intermittent fasting diet and calorie restricted diet. In addition, to generate random sequences, we use online software for random generation software allocation Random, which perform simple or blocked random sequences.
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 Tehran University of Medical Sciences
Street address
Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141556117
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.682

Health conditions studied

1

Description of health condition studied
fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Glucose oxidase enzymatic method using commercial kits of Pars Azmoon company in terms of (mg/dL)

2

Description
Total cholesterol
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Measurement of total cholesterol level using Pars Azmoon kits and auto analyzer

3

Description
Triglyceride
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Measurement of triglyceride level using Pars Azmoon kits and auto analyzer

4

Description
HDL cholesterol
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Measurement of HDL cholesterol level using Pars Azmoon kits and auto analyzer

5

Description
LDL cholesterol
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Measurement of LDL cholesterol by Friedwald formula [LDL = Chol - (TG / 5 + HDL)], with plasma triglyceride concentrations below 400 mg/dL.

6

Description
Aspartate transaminase enzyme (AST)
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Proposed IFCC method - Photometry Pars azmoon Kit

7

Description
Alanin transaminase enzyme (ALT)
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Proposed IFCC method - Photometry Pars azmoon Kit

8

Description
Gamma glutamyl transferase enzyme (GGT)
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Calorimetric-kinetic method proposed by IFCC

9

Description
Steatosis
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Fibroscan

10

Description
Hepatic fibrosis
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Fibroscan

11

Description
Fasting blood insulin level
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Special laboratory kit

12

Description
HOMA-IR
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Using the formula

13

Description
QUICKI
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Using the formula

14

Description
Weight
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Use digital scales with an accuracy of 0.1 kg and with minimal clothing and no shoes

15

Description
BMI
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Weight in kilograms divided by height squared in meters

16

Description
Waist circumference
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Tape meter

17

Description
Physical activity
Timepoint
At the beginning and end of the study (after 12 weeks (84 days))
Method of measurement
Record physical activity

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, an intermittent fasting diet of the type (16: 8) will be used, in which individuals are allowed to receive only water and non-energy drinks for 16 hours (from 8 pm to 12 am the next day). Tea, coffee and sugar-free chewing gum are free to eat for 8 hours (from 12 noon to 8 pm).
Category
Treatment - Other

2

Description
Control group: People in the control group also receive a low-calorie diet (which is adjusted based on the history taken during the run-in period as well as the foods that are in the eating habits of the people). To adjust diet with a macronutrient ratio of 55% carbohydrate, 30% fat and 15% protein, first using the current age, sex, height and weight of patients in the Harris Benedict formula, the basal metabolic rate (BMR) of patients is calculated individually. Then, the total daily energy requirement of each person is calculated based on his physical activity and taking into account the thermogenic effect of food (TEF), and finally, the total calculated energy is reduced by 300 kcal. Based on these divisions, the required amounts from each food group will be calculated. The control group diet will be divided into six daily meals including 3 main meals and 3 snacks. Based on this, a food menu will be set up and the necessary alternatives will be taught to the people in the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Masoud Clinic
Full name of responsible person
Hossein imani
Street address
No. 144, North Alley 19, Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 21 8833 6300
Email
contact@masoudclinic.com
Web page address
https://www.masoudclinic.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Footohi
Street address
Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossien Imani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
0098 21 889900285
Email
h_imani@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojatost Alley, Keshavarz Boulevard, Naderi St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8899 0285
Email
h-imani@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Karimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
West Shariat Alley 1 - No. 92
City
Shahre Jadid Hashtgerd
Province
Alborz
Postal code
3361848343
Phone
+98 26 4426 6104
Email
mehdi.karimi2097@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to confidentiality of participant information, it is not possible to publish it
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Not applicable
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