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

Investigating the consumption of vegetable butter containing resistant starch on the level of cholesterol, blood fat, blood sugar, liver enzymes and antibodies

This study is conducted in the form of a parallel study including two control and intervention groups, blinded and randomized in the third phase. 70 people including two groups of 35 people will enter the study. Randomization will be based on the lottery method.

This trial will be conducted in Alborz University of Medical Sciences, qualified people will be enrolled in the study and will be present in the study for six weeks. In this study, the appearance of butter with and without resistant starch is similar to each other, and the participants, the doctor, and the person who conducts the final evaluation are unaware of the type of butter received by the people, and only the main researcher of the project knows what type of butter each person has. has received

People aged thirty to sixty with a body mass index below 30

The control group will receive low-fat vegetable butter without resistant starch and the intervention group will receive low-fat vegetable butter containing resistant starch for six weeks.

Level of cholesterol

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.

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.

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.

Access starts 6 months after results are published

All researchers working in academic and scientific institutions and people working in the related industries.

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.

From the project manager, Dr. Hadi Pourjafar pourjafarhadi59@gmail.com

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.