]>
IRCT20160117026069N8 IRCT 2023-12-03 Behinehwazin Company Effect of low-fat vegetable butter enriched with peribiotic on the level of blood lipid factors, liver enzymes, and immune system function Study of the effect of consuming low-fat vegetable butter enriched with resistant starch on the level of blood lipid factors, liver enzymes, and immune system function in 30-60 years adults - A Triple-blinded, randomized clinical trial 2023-11-29 anticipated 70 Complete https://irct.ir/trial/73978 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: A number of 70 sealed envelopes, half of which contain code A and half contain code B, will be given to the participants to choose an envelope by lottery. People who choose package A will be given prebiotic butter and people who choose package B will be given normal butter. So the grouping of people will be random and the randomization list will not be predictable, Blinding description: Prebiotic butter will be given to the intervention group and normal butter to the control group. The weight and appearance of both types of butter will be similar, and only the main researcher of the project will know which type of butter each person received. Other people, including the participant, the person who evaluates the health of the people, laboratory experts and the person doing the statistical analysis is unaware of which butter each person consumes. 3 Condition 1: Hyperlipidemia. Condition 2: Hypercholesterolemia. Condition 3: Hyperglycemia. Condition 4: High level of liver enzymes. Condition 5: Level of Abs. Intervention 1: Control group: Daily consumption of 50 grams of low fat vegetable butter without resistant starch made by Mahgol factory for six weeks with each meal as desired by the participant. Intervention 2: Intervention group: Daily consumption of 50 grams of low fat vegetable butter enriched with resistant starch made by Mahgol factory for six weeks with each meal as desired by the participant. Yes - There is a plan to make this available What will be shared: All non-identifiable personal data of participants, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in analysis, and data dictionary will be shared after the end of the study. When: Access starts 6 months after results are published To whom: All researchers working in academic and scientific institutions and people working in the related industries. Conditions: The data can be analyzed and used within the framework of the study protocol, but the right to publish the data will be with the research team, and if the data is published by other people, it is necessary to mention the source. People who wish to have access to data or documents should send their written request to Dr. Hadi Pourjafar's email and explain their reason for needing these data or documents and how they will use them. If a request with this theme is received, a decision will be made with the opinion of the research team and taking into account the job title of the applicant and the content of the written request sent by him. Where to obtain: From the project manager, Dr. Hadi Pourjafar pourjafarhadi59@gmail.com How to obtain: he applicant must first submit a request including the requested data or document, the reason for the need for this data or document and the uses he will make of it along with a brief introduction of himself and his company or university to Mr. Hadi Pourjafar. After submitting the application to the project manager, this application will be reviewed at the earliest opportunity and within two weeks after receiving the application in a meeting with the presence of all those involved in the project. will be provided to the applicant. Comments:
public Hadi Pourjafar
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 pourjafarhadi59@gmail.com Karaj University of Medical Sciences scientific Hadi Pourjafar
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 pourjafarhadi59@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) between 30-60 years old BMI below 30 30 years 60 years Both History of hyperlipidemia History of high blood cholesterol Cardiovascular diseases Diabetes Liver diseases Kidney diseases Underlying and chronic diseases Allergy to vegetable butter Allergy to additives Digestive disorders E78.5 Hyperlipidemia, unspecified Placebo Other Control group: Daily consumption of 50 grams of low fat vegetable butter without resistant starch made by Mahgol factory for six weeks with each meal as desired by the participant Intervention group: Daily consumption of 50 grams of low fat vegetable butter enriched with resistant starch made by Mahgol factory for six weeks with each meal as desired by the participant Total Cholestrol. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. HDL (High Density Lipoprotein) Cholesterol. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. LDL (Low Density Lipoprotein) Cholesterol. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Triglyceride. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Serum Glutamic Oxaloacetic Transaminase (SGOT). Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Serum Glutamic Pyruvic Transaminase (SGPT). Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Alkaline Phosphatase (ALP). Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. IgA. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. IgM. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. IgG. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. HbA1C. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Fasting Blood Sugar (FBS). Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Use a lab kit. Behinehwazin Company Approved 2023-11-04 Alborz university of medical sciences Research deputy of Alborz medical science university,Saffarian Alley, Golshahr Blvd. Karaj Karaj Alborz Iran (Islamic Republic of)