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The effects of intermittent fasting diet with calorie restriction compared to calorie restriction diet on weight management, lipid profile, glycemic status, hormonal parameters, food addiction, appetite and gut microbiome population in people with 2-year weight regain After sleeve surgery: a randomized clinical trial

The effects of intermittent fasting diet with calorie restriction compared to calorie restriction diet on weight management, lipid profile, glycemic status, hormonal parameters, food addiction, appetite and gut microbiome population in people with 2-year weight regain After sleeve surgery: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091114002709N64
Enrollment
60
Registered
2024-08-09
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity. Obesity due to excess calories

Interventions

Intervention 1: Intervention group: In this group, participants will be taught that they will be allowed to eat freely from 11 am to 7 pm (for 8 hours). While from 7 pm to 11 am tomorrow (16 hours), p
Hello, good evening. "Between 7:00 PM and 11:00 AM tomorrow" is your fasting time (the message will be sent at 7:00 PM). In addition, the prescribed amount of calories is calculated based on the recal

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Willingness to participate in the study and complete the informed consent form based on knowledge and consent to participate in the study At least 2 years have passed since the person's surgery Weight gain again after surgery (weight gain again after surgery based on the definition of returning 10% of The lowest recorded weight after surgery (Nadir))

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding alcohol consumption Any addiction to opioids such as cigarettes Consumption of prebiotic or probiotic products during the last month History of hospitalization during the last three months Participating in another study within the last two months Following a special diet

Design outcomes

Primary

MeasureTime frame
Weight. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention) and 3 months after the end of the study. Method of measurement: Body weight will be measured fasting, without shoes, with minimal clothing and using a digital scale (Seca, Hamburg, Germany) with an accuracy of 100 grams.

Secondary

MeasureTime frame
Glycemic indices. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: Before and after the end of the intervention, 10 ml of blood samples are taken from each person in a 12-hour fasting state, and the serum sample is separated from the whole blood by a centrifuge for 10 minutes at 3500 rpm. The serum and whole blood samples are immediately frozen at -70°C until the relevant tests are performed. The standard enzyme method with commercial kits available in the market (Pars Azmon) is used to calculate insulin and FBS, HbA1c is checked by measuring in whole blood by cation exchange chromatography and using the Nyco Card HbA1c kit (Oslo, Norway). .;Lipid profile. Timepoint: TC and TG serum concentrations will be measured using laboratory methods, respectively, through enzymes such as cholesterol esterase, cholesterol oxidase, and glycerol phosphate oxidase and using standard kits. HDL will be measured after precipitation of Apolipoprotein B, which includes lipoproteins, with phosphotungstic acid. The amount of LDL will be measured using the values ??of TC, TG, HDL and by existing formulas. Method of measurement: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study).;Hormonal biomarkers. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study). Method of measurement: At the beginning and end of the study, 10 cc of venous blood will be extracted from the participants without the need to be fasting by qualified people. The blood sample was centrifuged, and the serum was stored at -80°C, and then the ELISA assay kit will be used to measure the levels of GLP-1, ghrelin, and BDNF.;Gut microbiome population. Timepoint: The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Shidfar

Iran University of Medical Sciences

farzadshidfar@yahoo.com+98 21 8670 1021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026