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General information
2021-05-03, 1400/02/13
2021-12-06, 1400/09/15
2021-0512-0306 00:00:00
2021-07-04, 1400/04/13
2022-01-05, 1400/10/15
20212022-0701-0405 00:00:00
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Recruitment start date delayed due to Covid-19 pandemic and changed to December 2021.
Recruitment start date delayed due to Covid-19 pandemic and changed to December 2021.
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زمان شروع بیمارگیری به علت پاندمیک کوید-19 به تاخیر افتاده است و به آذرماه 1400 تغییر پیدا کرد.
زمان شروع بیمارگیری به علت پاندمیک کوید-19 به تاخیر افتاده است و به آذرماه 1400 تغییر پیدا کرد.
Protocol summary
Study aim
If appropriate, it is recommended to use probiotic yogurt in the diet of patients with non-alcoholic fatty liver
Design
A clinical trial with a control group, parallel group, randomized groups, on 68patients. lottery container was used for randomization.
Settings and conduct
A controlled clinical trial will be performed at the Gastroenterology Clinic. Before the intervention, anthropometric indices, blood pressure, liver enzymes, glycemic index, insulin resistance, hepatic steatosis, liver fibrosis and lipid profile will be evaluated in all subjects. Individuals will be randomly divided into intervention and non-intervention groups. Intervention: 300 g daily probiotic yogurt for 12 weeks, control: 300 g normal yogurt daily for 12 weeks. The yogurts have the same color, shape, taste and smell are used so that the researcher and the patient are not aware of its type and only our distributor is aware of its type.
Participants/Inclusion and exclusion criteria
1. Patients with non-alcoholic fatty liver disease, 2. Aged 18-65 years, 3. Body mass index between 25-35 kg/m2. 4. Patients have a fixed plan for medication use during the last 3 months.
Intervention groups
Intervention: daily 300g probiotic yogurt for 12 weeks, control: 300g normal yogurt for 8 weeks
Main outcome variables
Steatosis, fibrosis and liver enzymes including ALT, AST and GGT.
General information
Reason for update
Recruitment start date delayed due to Covid-19 pandemic and changed to December 2021.
Acronym
IRCT registration information
IRCT registration number:IRCT20210201050210N1
Registration date:2021-04-19, 1400/01/30
Registration timing:prospective
Last update:2021-06-21, 1400/03/31
Update count:1
Registration date
2021-04-19, 1400/01/30
Registrant information
Name
Sara Ebrahimi-Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 3287
Email address
s-ebrahimim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of daily consumption of probiotic yogurt on liver enzymes steatosis and fibrosis in patients with nonalcoholic fatty liver disease
Public title
Effect of daily consumption of probiotic yogurt in patients with non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-alcoholic fatty liver disease was approved by a gastroenterologist using fibroscan examination
Individuals aged 20 to 60 years
Patients have a fixed plan for medication use during the last 3 months
Body mass index between 25 to 35 kg/m 2
Exclusion criteria:
Smokers
History of alcohol consumption
Adherence to a special diet in the last 3 months
Pregnant or lactating women or those planning to get pregnant in the next three months
Menopausal women
Individuals with pathologic conditions affecting the liver, including acute and chronic hepatitis, viral hepatitis, liver transplantation, autonomic hepatitis, hemochromatosis, primary biliary cirrhosis, Wilson's disease, antitrypsin deficiency and thyroid disease
People with lactose intolerance
People taking antibiotics
patients taking medications affecting serum lipids
Individuals taking multivitamin-minerals during the previous month
Patients who have used any type of probiotic product in the last two months
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be classified based on age(20-40/40-60), gender (male/female) and BMI (25-30/30-35) 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)
Double blinded
Blinding description
The shape, appearance, packaging, color and smell of both probiotic and non-probiotic yogurts will be quite similar. In addition, the person who provides yogurts to patients is aware of the type of yogurt, but the researcher and the patient are not aware of it.
Placebo
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
First Floor, Faculty of Medicine, Building No. 1, North Door of the University, POURSINA St, GHODS St, ENGHELAB St
City
Tehran
Province
Tehran
Postal code
14155-6117
Approval date
2021-01-20, 1399/11/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1006
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
Hepatic steatosis
Timepoint
Beginning the intervention and 12 weeks later at the end of the intervention
Method of measurement
Fibro-scan
2
Description
Hepatic fibrosis
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: They will receive 300g of probiotic yogurt enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 12 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g.
Category
Rehabilitation
2
Description
Control group: Control group: 300g will receive conventional yogurt for 12 weeks