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IRCT20190317043084N2 IRCT 2026-10-19 Oroumia University of Medical Sciences Effects of a Fasting-Mimicking Diet and Synbiotic Supplementation in Obese Adults with Metabolic Syndrome Investigating the effect of a fasting-mimicking diet and synbiotic supplementation on SIRT1 gene expression, serum IGF-1 level, insulin resistance index, and metabolic parameters in obese adults with metabolic syndrome 2026-10-24 anticipated 186 Recruiting https://irct.ir/trial/93834 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization and description of the method: Stratified block randomization with an allocation ratio of 1:1:1 and variable block sizes will be used Unit of randomization: Individual Stratification factors: Sex (female/male) and body mass index (BMI) in two strata of 30–34.9 and ≥35 kg/m² Randomization tool: The random allocation sequence will be computer-generated by an independent researcher who is not involved in the implementation of the study Generation of the random allocation sequence: For each stratum, a separate random allocation sequence will be generated using variable block sizes and an allocation ratio of 1:1:1 to the three study groups Allocation concealment: The allocation sequence will be placed in opaque, sealed, sequentially numbered envelopes, and the envelope corresponding to each participant will be opened only after eligibility criteria have been confirmed, written informed consent has been obtained, and the participant has been definitively enrolled in the study, Blinding description: Due to the nature of the dietary intervention, complete blinding of participants to receiving the FMD or usual diet is not feasible. However, participants will be blinded to the type of supplement received (synbiotic or placebo). The synbiotic supplement and placebo will be identical in appearance, packaging, and taste and will be provided in coded containers. The researcher responsible for implementing the intervention will be aware of the group allocation and the type of supplement received by each participant and therefore will not be blinded to group allocation. Outcome assessors and personnel responsible for data collection will be blinded to the participants’ group allocation, and information regarding group assignment will not be disclosed to them. The data analyst will also be blinded to group allocation. Data will be provided using anonymous group codes, such as A, B, and C. The group codes will remain concealed from the data analyst until completion of the primary statistical analysis. N/A Obesity. Intervention 1: Intervention group 1: Participants will receive a fasting mimicking diet for 3 months, consisting of one 5 day cycle each month, while continuing their usual diet on the remaining days. Energy intake will be approximately 1100 kcal on day 1 and 700 to 800 kcal on days 2 to 5. The diet will be plant based, low calorie, low protein, and designed with a higher proportion of unsaturated fats. Standardized daily food packs will be provided to participants. They will also take one placebo capsule daily for 12 weeks. Intervention 2: Intervention group 2: Participants will receive the same fasting mimicking diet as intervention group 1 for 3 months, along with one capsule of FamiLact synbiotic, manufactured by Zist Takhmir, Iran, daily for 12 weeks. Each capsule contains approximately 10⁹ colony forming units of probiotics along with the prebiotic fructooligosaccharide. Intervention 3: Control group: Participants will continue their usual diet and receive general healthy eating recommendations. They will take one placebo capsule daily for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the nature of the individual-level data and confidentiality and research ethics considerations, there is no plan to share the individual-level de-identified participant data after completion of the study.
public Laleh Payahoo
Department of Nutrition Sciences, Faculty of Medicine, Urmia University of Medical Sciences, Nazlu road
Urmia Iran (Islamic Republic of) 5756115198 +98 44 3275 2372 llllpayahoo44@gmail.com Oroumia University of Medical Sciences scientific Laleh Payahoo
Department of Nutrition Sciences, Faculty of Medicine, Urmia University of Medical Sciences, Nazlu road
Urmia Iran (Islamic Republic of) 5756115198 +98 44 3275 2372 llllpayahoo44@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Participants aged 18 to 55 years with obesity, defined as a body mass index (BMI) greater than 30 kg/m², and central obesity, defined as a waist circumference of 94 cm or more in men and 80 cm or more in women Meeting at least two of the metabolic criteria for metabolic syndrome Serum triglyceride level of 150 mg/dL or higher or receipt of specific pharmacological treatment HDL-C level lower than 40 mg/dL in men and lower than 50 mg/dL in women or receipt of relevant treatment Systolic blood pressure of 130 mmHg or higher and/or diastolic blood pressure of 85 mmHg or higher or use of antihypertensive medications Fasting blood glucose of 100 mg/dL or higher or a history of confirmed type 2 diabetes mellitus 18 years 55 years Both Participants with chronic liver, kidney, or cardiovascular diseases Participants with malignancies Participants with inflammatory diseases or severe gastrointestinal disorders Participants with uncontrolled thyroid disorders Pregnant or breastfeeding women Current smoking or alcohol consumption Use of antibiotics within the previous three months Use of probiotic- or prebiotic-containing supplements within the previous three months Use of medications affecting metabolism Significant weight changes within the previous three months Known allergy or intolerance to the herbal components of the dietary intervention, the herbal teas used in the study, or the components of the synbiotic supplement E66 Overweight and obesity Treatment - Other Treatment - Other Placebo Intervention group 1: Participants will receive a fasting mimicking diet for 3 months, consisting of one 5 day cycle each month, while continuing their usual diet on the remaining days. Energy intake will be approximately 1100 kcal on day 1 and 700 to 800 kcal on days 2 to 5. The diet will be plant based, low calorie, low protein, and designed with a higher proportion of unsaturated fats. Standardized daily food packs will be provided to participants. They will also take one placebo capsule daily for 12 weeks. Intervention group 2: Participants will receive the same fasting mimicking diet as intervention group 1 for 3 months, along with one capsule of FamiLact synbiotic, manufactured by Zist Takhmir, Iran, daily for 12 weeks. Each capsule contains approximately 10⁹ colony forming units of probiotics along with the prebiotic fructooligosaccharide. Control group: Participants will continue their usual diet and receive general healthy eating recommendations. They will take one placebo capsule daily for 12 weeks SIRT1 gene expression. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Using real-time polymerase chain reaction (Real-time PCR). Serum IGF-1 level. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Using an enzyme-linked immunosorbent assay (ELISA) with a commercial kit. Insulin sensivity. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: It is calculated using fasting insulin and fasting glucose levels according to the following formula. Fasting blood glucose. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Fasting blood glucose will be measured in fasting serum samples using the enzymatic colorimetric method with commercial kits on an autoanalyzer (BT1500). Fasting serum insulin. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Fasting serum insulin will be measured using an ELISA kit and an ELISA reader (Stat Fax 4200), according to the manufacturer’s instructions. Total cholesterol. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Total cholesterol will be measured in fasting serum samples using enzymatic colorimetric kits from Pars Azmun and a BT1500 autoanalyzer, according to the manufacturer’s instructions. Triglycerides(TG). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Triglycerides will be measured in fasting serum samples using enzymatic colorimetric kits from Pars Azmun and a BT1500 autoanalyzer, according to the manufacturer’s instructions. HDL. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: HDL will be measured in fasting serum samples using enzymatic colorimetric kits from Pars Azmun and a BT1500 autoanalyzer, according to the manufacturer’s instructions. LDL. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: LDL will be measured in fasting serum samples using enzymatic colorimetric kits from Pars Azmun and a BT1500 autoanalyzer, according to the manufacturer’s instructions. High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: High-sensitivity C-reactive protein (hs-CRP) will be measured in fasting serum samples using high-sensitivity ELISA kits and an ELISA reader (Stat Fax 4200), according to the manufacturer’s instructions. Body weight. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Body weight will be measured with light clothing and without shoes using a calibrated digital scale (Beurer, Germany) with an accuracy of 0.1 kg. Body fat percentage. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Body fat percentage will be measured using a bioelectrical impedance analysis (BIA) body composition analyzer, InBody 270 (Korea), in a standing position without shoes. Muscle mass. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Body fat percentage will be measured using a bioelectrical impedance analysis (BIA) body composition analyzer, InBody 270 (Korea), in a standing position without shoes. Changes in energy and macronutrient intake. Timepoint: At weeks 0, 6, and 12. Method of measurement: Based on a food frequency questionnaire (FFQ) and 24-hour dietary recalls. Physical activity level. Timepoint: At weeks 0, 6, and 12. Method of measurement: Based on a METs questionnaire. Oroumia University of Medical Sciences Approved 2026-09-16 Ethics Committee of Urmia University of Medical Sciences Department of Nutrition Sciences, Faculty of Medicine, Urmia University of Medical sciences, Nazlu road Urmia West Azarbaijan Iran (Islamic Republic of)