The Effect of Time-Restricted Eating versus Standard Dietary Advice on Arterial Stiffness Indices in Men with Metabolic Syndrome

Determining the effect of time-restricted eating versus standard dietary advice on arterial stiffness indices in men with metabolic syndrome

Clinical trial with control group, with parallel groups, without blinding, simple randomization, using sealed envelopes and random numbers with the help of Randomaize.com, on 48 patients

A meal containing 500 kcal (50% carbohydrates, 20% protein and 30% fat) will be provided at the beginning and end of the study. Then, in the fasting state, 60 minutes later and 120 minutes later, the blood sample is taken. Weight, height, waist circumference, bioelectrical impedance analysis (BIA), complete blood count (CBC), liver function (ALT, AST), CRP, lipid profile, glucose, insulin, insulin resistance, blood pressure, Pulse Wave Velocity (PWV) and indirect calorimetry will be evaluated at the beginning of the study and after 6 weeks. In the third week, weight, blood pressure, lipid profile, glucose, insulin and insulin resistance will be measured.

Inclusion criteria: Men between the ages of 18 and 65, Body mass index (BMI) below 35, Specific work and sleep schedule, The duration of receiving daily food more than 14 hours, Diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF) definition Non-inclusion criteria: Diabetes, People being treated for hyperglycemia or hypercholesterolemia or hypertension, Thyroid disorders based on thyroid tests or thyroxine use, Eating disorders, Serious diseases that affect food intake such as cancer, Using supplements that contain compounds other than vitamins and minerals, Inability to follow time-restricted eating diet

Intervention group: time-restricted diet (they will receive food in a 10-hour period.) Control group: diet without time restriction

Pulse Wave Velocity (PWV)

Due to the prolongation of the patient screening process (according to the inclusion and exclusion criteria) and the failure of some required devices, the sampling starts with a delay.

Randomization method: simple Randomization Unit: Individual Randomization tool: sealed envelope (SNOSE: sequentially numbered, opaque, sealed envelopes) How to make a random sequence: Randomaize.com randomization site Explanation about allocation concealment: Random numbers are prepared with the help of Randomaize.com and printed and placed inside the envelope by a member of the research team. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then first, the purpose of the study is explained to the person who meets the listed conditions. If desired, the person signs the informed consent form and takes an envelope. Then opens it and based on the contents of the envelope, the person is entered in the intervention or control group.

Some collected data including the results of primary outcome measures will be presented.

Access to data will be granted 6 months after publication.

Data will be accessible for people working in academic institutions and people working in businesses upon request.

Criteria for sharing deidentified data or other products will be evaluated based on case-by-case approach by the Mashhad University of Medical Sciences.

Dr. Mohsen Nemati Address: Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, East door of Ferdowsi University, Azadi Sq., Mashhad Iran Post code: 9177948564 Email: NematyM@mums.ac.ir Phone number: 0098 51 38827034

Applicants should submit their detailed request through email. Their request will be evaluated by the researchers and the Mashhad University of Medical Sciences and will be available to the applicant if approved by the organization.