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
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 70 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 or taking multi-vitamin and mineral 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, fibrosis and liver enzymes including ALT, AST and GGT.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210119050086N1
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
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
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
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 or taking multivitamin-mineral supplements 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:
70
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
Fibrosis
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Fibro-scan
2
Description
Steatosis
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Fibro-scan
3
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))
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.