Protocol summary
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Study aim
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If appropriate, it is recommended to use probiotic yogurt in the diet of patients with non-alcoholic fatty liver
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Design
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A clinical trial with a control group, parallel group, randomized groups, on 68patients. lottery container was used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention: daily 300g probiotic yogurt for 12 weeks, control: 300g normal yogurt for 8 weeks
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Main outcome variables
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Steatosis, fibrosis and liver enzymes including ALT, AST and GGT.
General information
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Reason for update
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Recruitment start date delayed due to Covid-19 pandemic and changed to December 2021.
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Acronym
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IRCT registration information
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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
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Registration date
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2021-04-19, 1400/01/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-06, 1400/09/15
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Expected recruitment end date
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2022-01-05, 1400/10/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of daily consumption of probiotic yogurt on liver enzymes steatosis and fibrosis in patients with nonalcoholic fatty liver disease
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Public title
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Effect of daily consumption of probiotic yogurt in patients with non-alcoholic fatty liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-20, 1399/11/01
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.1006
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Hepatic steatosis
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Fibro-scan
2
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Description
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Hepatic fibrosis
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Fibro-scan
3
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Description
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Liver enzyme (ALT, AST and GGT)
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Blood sample
Secondary outcomes
1
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Description
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Lipid profile (TG, Total cholesterol, LDL-c and LDH-c)
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Blood sample
2
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Description
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Glycemic index (FBS, FBI, HOMA-IR and QUICKI)
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Blood sample
3
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Description
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Weight
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Scales
4
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Description
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Waist circumference
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Tape meter
5
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Description
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Body mass index (BMI)
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Timepoint
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Beginning the intervention and 12 weeks later at the end of the intervention
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Method of measurement
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Formula (weight (kilograms) divided by the squared height (meters))
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: Control group: 300g will receive conventional yogurt for 12 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available