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IRCT20110510006431N7 IRCT 2023-11-19 Shahid Beheshti University of Medical Sciences Investigating the effect of royal jelly supplement in non-alcoholic fatty liver disease Investigating the effect of royal jelly supplementation on blood lipids, liver enzymes, insulin resistance and inflammatory factors in patients with non-alcoholic fatty liver disease: a double-blind randomized clinical study 2023-11-06 anticipated 46 Complete https://irct.ir/trial/71885 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are divided into 2 intervention groups (as a group receiving royal jelly supplement) and a control group (as a group receiving placebo), in order to randomly assign patients to two groups, the stratified block randomization method is used to Randomization is performed by a block randomization program provided by an external randomization service based on age and gender. An investigator will screen and enroll participants, and the randomization sequence will be performed sequentially through identical sealed capsule containers assigned to participants at enrollment. The randomization code will be provided in sealed envelopes only to be broken at the end of the clinical trial ( before statistical analysis) or in the event of serious adverse events, Blinding description: The participants are randomly assigned to the royal jelly or placebo arm (23 people in each group) using a random number table, so that they are not aware of the drug or placebo use. In this study, patients in the intervention group received 3 capsules of 1000 mg daily for 8 weeks, and patients in the control group received a type of placebo supplement that looks exactly like Royal Gel capsules. Due to the double-blindness of the study, the researcher who was taking and recording the data of the samples was also blind to the drug or placebo in the samples, and only the statistician would be aware of their placement in each of the two mentioned groups. 2-3 Non-alcoholic fatty liver. This study is a randomized, double-blind, placebo-controlled trial for 8 weeks. The participants are randomly assigned to the royal jelly or placebo arm (23 people in each group) without knowing about the drug or placebo. In this study, the patients of the intervention group received 3 capsules of 1000 mg daily with the active ingredient 10-hydroxy-2-desenoic acid for 8 weeks, and the patients of the control group received a type of placebo supplement that looks exactly like the royal gel capsule. This supplement and placebos will be prepared and supplied by Koze Asal Company. Due to the double-blindness of the study, the researcher who was taking and recording the data of the samples was also blind to the drug or placebo in the samples, and only the statistician would be aware of their placement in each of the two mentioned groups.Randomization is done by a block randomization program provided by an external randomization service. An investigator will screen and enroll participants, and the randomization sequence will be performed sequentially through identical sealed capsule containers assigned to participants at enrollment. The randomization code will be provided in sealed envelopes only to be broken at the end of the clinical trial (before statistical analysis) or in the event of serious adverse events. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is possible to publish
public fateme hasannia
jahanara
Tehran Iran (Islamic Republic of) 1436674534 +98 21 8804 2491 hasannia.fatemeh76@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahdi Shadnoush
Hafezi
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years diagnosis of NAFLD using ultrasound imaging Body mass index (BMI) 25 and above fasting blood sugar less than 126 no history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men 18 years 65 years Both Smoking history of liver, cardiovascular, pulmonary, kidney disease, celiac disease use of lipid-lowering drugs regular exercise six months before the study basic diet changes weight change of more than 5% in 3 months before screening History of gastric surgeries for weight loss patients using dietary supplements containing n-3 or n-6 fatty acids, vitamin D, E and other antioxidants or fiber supplements in the 12 weeks before the start of the study history of thyroid problems non-compliance Principles of the study protocol K76.0 Fatty (change of) liver, not elsewhere classified Placebo This study is a randomized, double-blind, placebo-controlled trial for 8 weeks. The participants are randomly assigned to the royal jelly or placebo arm (23 people in each group) without knowing about the drug or placebo. In this study, the patients of the intervention group received 3 capsules of 1000 mg daily with the active ingredient 10-hydroxy-2-desenoic acid for 8 weeks, and the patients of the control group received a type of placebo supplement that looks exactly like the royal gel capsule. This supplement and placebos will be prepared and supplied by Koze Asal Company. Due to the double-blindness of the study, the researcher who was taking and recording the data of the samples was also blind to the drug or placebo in the samples, and only the statistician would be aware of their placement in each of the two mentioned groups.Randomization is done by a block randomization program provided by an external randomization service. An investigator will screen and enroll participants, and the randomization sequence will be performed sequentially through identical sealed capsule containers assigned to participants at enrollment. The randomization code will be provided in sealed envelopes only to be broken at the end of the clinical trial (before statistical analysis) or in the event of serious adverse events TG،Total Cholestrol ، LDL ، HDL C ،ALT، AST ،GGT ، TNF a ، CRP. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: 5 cc of blood is taken to measure the concentration of liver enzymes, lipid profile, inflammatory factors and it is measured by enzymatic methods and using a kit. Weight, body mass index (BMI), waist circumference, hip circumference, ratio of waist circumference to hip circumference, serum glucose, serum insulin, insulin resistance (HOMA-IR), quantitative insulin sensitivity index (QUICKI). Timepoint: At the beginning of the study and after 8 weeks after the intervention. Method of measurement: Taking blood samples using laboratory methods, the weight of each patient is measured with a scale with an accuracy of 100 grams, and the height of each patient without shoes is measured with a height meter with an accuracy of 0.5 cm. The body mass index (BMI) of the patients is calculated, the patient's waist and hips are measured using a tape measure with an accuracy of 0.5 cm, and finally, the body fat percentage of the patients is measured with an in-body device. Hospital Approved 2023-10-17 Ethics committee of Farhikhtegan Hospital-Islamic Azad university Tehran, the end of Shahid Sattari North Highway, University Square, towards Hesarek, Farhikhtegan Hospital Tehran Tehran Iran (Islamic Republic of)