The effect of moderate carbohyderate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease: a parallel randomized controlled clinical trials
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Protocol summary
A clinical trial with a control group, parallel group, randomized groups, on 68 patients. lottery container was used for randomization.
A clinical trial with a control group, parallel group, randomized groups, on 52 patients. lottery container was used for randomization.
A clinical trial with a control group, parallel group, randomized groups, on 6852 patients. lottery container was used for randomization.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تصادفی شده، بر روی 68 بیمار. برای تصادفی سازی از گلدان استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تصادفی شده، بر روی 52 بیمار. برای تصادفی سازی از گلدان استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تصادفی شده، بر روی 6852 بیمار. برای تصادفی سازی از گلدان استفاده شد.
Inclusion criteria: 1.Body mass index between 18.5-25 kg/m2, 2. Aged 18-65 years, 3.Patients with non-alcoholic fatty liver disease.
Non-inclusion criteria: 1.Consuming alcohol, 2.Pregnancy and breastfeeding 3. Suffering from other liver diseases, 4. Drug and tobacco use, 5. Consuming corticosteroids or taking multi-vitamin and mineral during the last three months, 6. Follow a weight loss diet during the last three months.
Inclusion criteria: 1.Body mass index between 18.5-25 kg/m2, 2. Aged 18-65 years, 3.Patients with non-alcoholic fatty liver disease.
Non-inclusion criteria: 1.Consuming alcohol, 2.Pregnancy and breastfeeding 3. Suffering from other liver diseases, 4. Drug and tobacco use, 5. Consuming corticosteroids during the last three months, 6. Follow a weight loss diet during the last three months.
Inclusion criteria: 1.Body mass index between 18.5-25 kg/m2, 2. Aged 18-65 years, 3.Patients with non-alcoholic fatty liver disease. Non-inclusion criteria: 1.Consuming alcohol, 2.Pregnancy and breastfeeding 3. Suffering from other liver diseases, 4. Drug and tobacco use, 5. Consuming corticosteroids or taking multi-vitamin and mineral during the last three months, 6. Follow a weight loss diet during the last three months.
شرایط ورود: 1. نمایه توده بدنی 25-18/5 کیلوگرم بر متر مربع، 2. محدوده سنی 65-18 سال، 3. بیمار مبتلا به کبد چرب غیرالکلی.
شرایط عدم ورود: 1. مصرف مشروبات الکلی، 2. بارداری و شیردهی، 3. ابتلا به سایر بیماری های کبدی، 4. مصرف کورتیکواستروئیدها و مکمل های مولتی ویتامین- مینرال در طی سه ماه اخیر. 5. مصرف دخانیات یا مواد مخدر. 6. پیروی از رژیم کاهش وزن در طی سه ماه اخیر.
شرایط ورود: 1. نمایه توده بدنی 25-18/5 کیلوگرم بر متر مربع، 2. محدوده سنی 65-18 سال، 3. بیمار مبتلا به کبد چرب غیرالکلی.
شرایط عدم ورود: 1. مصرف مشروبات الکلی، 2. بارداری و شیردهی، 3. ابتلا به سایر بیماری های کبدی، 4. مصرف کورتیکواستروئیدها در طی سه ماه اخیر. 5. مصرف دخانیات یا مواد مخدر. 6. پیروی از رژیم کاهش وزن در طی سه ماه اخیر.
شرایط ورود: 1. نمایه توده بدنی 25-18/5 کیلوگرم بر متر مربع، 2. محدوده سنی 65-18 سال، 3. بیمار مبتلا به کبد چرب غیرالکلی. شرایط عدم ورود: 1. مصرف مشروبات الکلی، 2. بارداری و شیردهی، 3. ابتلا به سایر بیماری های کبدی، 4. مصرف کورتیکواستروئیدها و مکمل های مولتی ویتامین- مینرال در طی سه ماه اخیر. 5. مصرف دخانیات یا مواد مخدر. 6. پیروی از رژیم کاهش وزن در طی سه ماه اخیر.
Steatosis, fibrosis and liver enzymes including ALT, AST and GGT.
Steatosis and liver enzymes including ALT, AST and GGT.
Steatosis, fibrosis and liver enzymes including ALT, AST and GGT.
استئاتوز، فیبروز و آنزیم های کبدی شامل ALT, AST و GGT.
استئاتوز و آنزیم های کبدی شامل ALT, AST و GGT.
استئاتوز، فیبروز و آنزیم های کبدی شامل ALT, AST و GGT.
General information
68
52
6852
Sampling has been delayed due to the covid-19 pandemic.
According to the formula and considering the possible drop-out, we will be need 68 participants and 70 participants have been registered incorrectly.
According to the formula and considering the possible drop-out, we will be need 52 participants and 68 participants have been registered incorrectly.
In the exclusion criteria section, according to the covid-19 pandemic and the individual's desire to use multivitamins to maintain and improve the immune system, we will include individuals who consume multivitamins and minerals.
In the primary and secondary outcomes section, considering that the duration of the intervention to investigate liver fibrosis is short, we will consider liver fibrosis as a secondary outcome.
Sampling has been delayed due to the covid-19 pandemic. According to the formula and considering the possible drop-out, we will be need 6852 participants and 7068 participants have been registered incorrectly. In the exclusion criteria section, according to the covid-19 pandemic and the individual's desire to use multivitamins to maintain and improve the immune system, we will include individuals who consume multivitamins and minerals. In the primary and secondary outcomes section, considering that the duration of the intervention to investigate liver fibrosis is short, we will consider liver fibrosis as a secondary outcome.
به علت شرایط پاندمی کوید-19 نمونه گیری به تاخیر افتاده است.
با توجه به فرمول و با در نظر گرفتن ریزش احتمالی به 68 شرکت کننده نیاز خواهیم داشت و به صورت اشتباه 70 شرکت کننده ثبت گردیده است.
با توجه به فرمول و با در نظر گرفتن ریزش احتمالی به 52 شرکت کننده نیاز خواهیم داشت و به صورت اشتباه 68 شرکت کننده ثبت گردیده است.
در بخش معیار های خروج، با توجه به شرایط پاندمی کووید-19 و تمال فرد به استفاده از مولتی ویتامین ها جهت حفظ سیستم ایمنی بدن، افرادی که مولتی ویتامین مینرال مصرف می کنند را وارد نمونه خواهیم کرد.
در بخش پیامد های اصلی و ثانویه نیز، با توجه به اینکه مدت زمان مداخله جهت بررسی فیبروز کبدی کوتاه می باشد، فیبروز کبدی را به عنوان پیامد ثانویه در نظر خواهیم گرفت.
به علت شرایط پاندمی کوید-19 نمونه گیری به تاخیر افتاده است. با توجه به فرمول و با در نظر گرفتن ریزش احتمالی به 6852 شرکت کننده نیاز خواهیم داشت و به صورت اشتباه 7068 شرکت کننده ثبت گردیده است. در بخش معیار های خروج، با توجه به شرایط پاندمی کووید-19 و تمال فرد به استفاده از مولتی ویتامین ها جهت حفظ سیستم ایمنی بدن، افرادی که مولتی ویتامین مینرال مصرف می کنند را وارد نمونه خواهیم کرد. در بخش پیامد های اصلی و ثانویه نیز، با توجه به اینکه مدت زمان مداخله جهت بررسی فیبروز کبدی کوتاه می باشد، فیبروز کبدی را به عنوان پیامد ثانویه در نظر خواهیم گرفت.
Alcohol consumption
Pregnancy or breastfeeding
Suffering from other liver diseases
Consuming corticosteroids or taking multivitamin-mineral supplements during the last three months
Drugs or tobacco use
Follow a weight loss diet during the last three months
Alcohol consumption
Pregnancy or breastfeeding
Suffering from other liver diseases
Consuming corticosteroids during the last three months
Drugs or tobacco use
Follow a weight loss diet during the last three months
Alcohol consumption Pregnancy or breastfeeding Suffering from other liver diseases Consuming corticosteroids or taking multivitamin-mineral supplements during the last three months Drugs or tobacco use Follow a weight loss diet during the last three months
مصرف مشروبات الکلی
بارداری و شیردهی
ابتلا به سایر بیماری های کبدی
مصرف کورتیکواستروئیدها و مکمل های مولتی ویتامین- مینرال در طی سه ماه اخیر
مصرف دخانیات یا مواد مخدر
پیروی از رژیم کاهش وزن در طی سه ماه اخیر
مصرف مشروبات الکلی
بارداری و شیردهی
ابتلا به سایر بیماری های کبدی
مصرف کورتیکواستروئیدها در طی سه ماه اخیر
مصرف دخانیات یا مواد مخدر
پیروی از رژیم کاهش وزن در طی سه ماه اخیر
مصرف مشروبات الکلی بارداری و شیردهی ابتلا به سایر بیماری های کبدی مصرف کورتیکواستروئیدها و مکمل های مولتی ویتامین- مینرال در طی سه ماه اخیر مصرف دخانیات یا مواد مخدر پیروی از رژیم کاهش وزن در طی سه ماه اخیر
Primary outcomes
#1
Fibrosis
Steatosis
FibrosisSteatosis
فیبروز
چربی کبدی
فیبروزچربی کبدی
#2
Steatosis
Liver enzyme (ALT, AST and GGT)
SteatosisLiver enzyme (ALT, AST and GGT)
چربی کبدی
آنزیم های کبدی (ALT،AST و GGT)
چربیآنزیم های کبدی (ALT،AST و GGT)
Fibro-scan
Blood sample
Fibro-scanBlood sample
فیبرواسکن
آزمایش خون
فیبرواسکنآزمایش خون
#3
Liver enzyme (ALT, AST and GGT)
empty
Liver enzyme (ALT, AST and GGT)
آنزیم های کبدی (ALT،AST و GGT)
empty
آنزیم های کبدی (ALT،AST و GGT)
Beginning the intervention and 12 weeks later at the end of the intervention
empty
Beginning the intervention and 12 weeks later at the end of the intervention
ابتدا مداخله و 12 هفته بعد در انتها مداخله
empty
ابتدا مداخله و 12 هفته بعد در انتها مداخله
Blood sample
empty
Blood sample
آزمایش خون
empty
آزمایش خون
Secondary outcomes
#1
empty
Fibrosis
Fibrosis
empty
فیبروز
فیبروز
empty
Beginning the intervention and 12 weeks later at the end of the intervention
Beginning the intervention and 12 weeks later at the end of the intervention
empty
ابتدا مداخله و 12 هفته بعد در انتها مداخله
ابتدا مداخله و 12 هفته بعد در انتها مداخله
empty
Fibro-scan
Fibro-scan
empty
فیبرواسکن
فیبرواسکن
Protocol summary
Study aim
Determining the effect of moderate carbohydrate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease
Design
A clinical trial with a control group, parallel group, randomized groups, on 52 patients. lottery container was used for randomization.
Settings and conduct
A controlled clinical trial will be performed at the Gastroenterology Clinic. Before the intervention anthropometric and biochemical assessment, steatosis and liver fibrosis assessment by Fibro-scan will be done. Individuals will be randomly divided into intervention and control groups. The subjects in the intervention group will be received a moderate carbohydrate-restricted diet, which included 40-45% of energy from carbohydrates, 35-40% of energy from fat, and the rest of energy from a source of protein for 12 weeks. The control group will be received an isocaloric diet for 12 weeks. The diet will be included 50-55% of energy from carbohydrates, 25-30% from fat, and the rest of energy from a source of protein.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Body mass index between 18.5-25 kg/m2, 2. Aged 18-65 years, 3.Patients with non-alcoholic fatty liver disease.
Non-inclusion criteria: 1.Consuming alcohol, 2.Pregnancy and breastfeeding 3. Suffering from other liver diseases, 4. Drug and tobacco use, 5. Consuming corticosteroids during the last three months, 6. Follow a weight loss diet during the last three months.
Intervention groups
Intervention group: intake of moderate carbohydrate restriction diet
Control group: intake of isocaloric diet
Main outcome variables
Steatosis and liver enzymes including ALT, AST and GGT.
General information
Reason for update
According to the formula and considering the possible drop-out, we will be need 52 participants and 68 participants have been registered incorrectly.
In the exclusion criteria section, according to the covid-19 pandemic and the individual's desire to use multivitamins to maintain and improve the immune system, we will include individuals who consume multivitamins and minerals.
In the primary and secondary outcomes section, considering that the duration of the intervention to investigate liver fibrosis is short, we will consider liver fibrosis as a secondary outcome.
Acronym
IRCT registration information
IRCT registration number:IRCT20210119050086N1
Registration date:2021-02-20, 1399/12/02
Registration timing:prospective
Last update:2022-08-28, 1401/06/06
Update count:2
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Fatemeh Dashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
fatemehda1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of moderate carbohyderate restriction diet on liver enzymes, steatosis and fibrosis in normal weight individuals with non-alcoholic fatty liver disease: a parallel randomized controlled clinical trials
Public title
Effect of moderate restriction diet in treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index 18.5-25 kg/m2
Age range 18-65 years
Patients with non-alcoholic fatty liver disease
Exclusion criteria:
Alcohol consumption
Pregnancy or breastfeeding
Suffering from other liver diseases
Consuming corticosteroids during the last three months
Drugs or tobacco use
Follow a weight loss diet during the last three months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be classified based on age, gender (male/female) and BMI (±2) into different blocks. To do randomization, an identification code will be given to each participant, and then the codes of each two participants with the same age, gender and BMI will be poured into the lottery container. Random allocation will be done by a person who is unaware of the study. The first code will be assigned to the intervention group, the second code to the control group and so other participants will be randomly assigned to the two groups.
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
Office of the Vice Chancellor for Research, First Floor, Building No. 1, School of Medicine, North Door of the University, Poursina St., Ghods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1411713114
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.964
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Steatosis
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Fibro-scan
2
Description
Liver enzyme (ALT, AST and GGT)
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Blood sample
Secondary outcomes
1
Description
Lipid profile (TG, Total cholesterol, LDL-c and LDH-c)
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Blood sample
2
Description
Glycemic index (FBS, FBI, HOMA-IR and QUICKI)
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Blood sample
3
Description
Weight
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Scales
4
Description
Waist circumference
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Tape meter
5
Description
Body mass index (BMI)
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Formula (weight (kilograms) divided by the squared height (meters))
6
Description
Fibrosis
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Fibro-scan
Intervention groups
1
Description
Intervention group: Intake of moderate carbohydrate restriction diet, which included 40-45% of energy from carbohydrates, 35-40% of energy from fat, and the rest of energy from a source of protein.
Category
Treatment - Other
2
Description
Control group: Intake of isocaloric diet, which included 50-55% of energy from carbohydrates, 25-30% from fat, and the rest of energy from a source of protein.