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IRCT20220522054958N4 IRCT 2025-10-22 National Institute for Medical Research Development(NIMAD) The Impact of Fast Diet on Lipocalin 2, Irisin, and Inflammatory Markers Examining the Impact of Fast Diet and Calorie Deficit Diet on Emerging Adipokines Lipocalin 2, Irisin, and Inflammatory Markers among Women with Obesity/Overweight: a Randomized Clinical Trial 2026-03-21 anticipated 50 Complete https://irct.ir/trial/86689 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: All participants will provide informed consent before entering the study. A physician and a trained nutritionist will thoroughly evaluate and inform the patients about the study's methodology, and written consent will be obtained. Demographic information will be collected using a questionnaire, and anthropometric measurements, such as BMI, waist-hip ratio, visceral fat area, body fat percentage, Waist circumference (WC), Hip circumference (HC), Mid-upper arm circumference (MUAC) and Forearm and calf circumference, will be recorded. The participants will then be randomized into either the intervention or control group using a random numbers table. Each individual will be assigned to either Group A, which follows the Fast Diet, or Group B, which follows the Calorie Deficit Diet. Prior to the intervention, a 20 cc blood sample will be collected from each participant to measure biochemical, adipokines, and inflammatory indices, Randomization description: Participants will undergo stratified randomization based on BMI (classified into two categories: 40 > BMI ≥ 30 and 30 > BMI ≥ 25) and age (classified into two categories: 50 > age ≥ 30 and 30 > age ≥ 18). Each subject will be ranked according to their age and BMI to ensure greater homogeneity between groups. Following this ranking, individuals will be assigned to either the control or intervention group using a random numbers table. Due to the nature of the intervention, blinding of participants to their group allocation is not feasible. An independent statistician, who remains blinded throughout the study, will generate the allocation sequences using a random numbers table. 1 Obesity or overweight. Participants will adhere to a prescribed diet for 12 weeks, tailored to their group and daily energy requirements, which are calculated using the Mifflin equation. The FD diet (5:2 intermittent fasting protocol) involves two fasting days per week, during which participants consume only 25% of their recommended caloric intake, and five feeding days, where they consume 100% of their calculated daily energy requirements across three main meals and three snacks. Feeding times are standardized: breakfast at 8:00, lunch at 13:00, dinner at 20:00, with snacks at 10:00, 16:00, and 22:00. The control group consumes 80% of their daily energy requirement with the same meal and snack schedule. Both groups follow these dietary plans for 12 weeks, with daily macronutrient distribution set at 55% carbohydrates, 30% fat, and 15% protein. Participants are monitored for any adverse effects, which are reported to the research staff, and no physical or psychological harm is anticipated from the study.. Yes - There is a plan to make this available What will be shared: All data can be shared after making participants anonymous. When: Six months after publishing results, everything will be accessible. To whom: The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions Conditions: With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination. Where to obtain: All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com How to obtain: Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant. Comments:
public Sadegh Jafarnejad
5th of Qotb –e Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 drsadegh2008@gmail.com Kashan University of Medical Sciences scientific Sadegh Jafarnejad
5th of Qotb –e Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 drsadegh2008@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) The study will focus exclusively on women aged 18 to 50 to eliminate potential confounding factors related to sex-based differences in hormonal profiles, body composition, and metabolic responses to dietary interventions. This age range focuses on women during their reproductive years and excludes women undergoing significant menopausal transitions (as stated in the proposal's rationale). BMI (25-40 kg/m2): Participants will have a BMI ranging from 25 to 40 kg/m2. This BMI range ensures that all participants meet the criteria for overweight or obesity, as defined by the World Health Organization (WHO). Absence of Specific Diets/Weight Loss Medications/Supplements: Participants should not be following a specific diet or taking weight loss medications, and should not be consuming dietary supplements for weight loss. This ensures that the observed effects are attributable to the assigned dietary intervention (FD or CR) and not influenced by pre-existing dietary habits or pharmacological interventions. Absence of History of Chronic Illnesses: Absence of a history of chronic illnesses such as heart disease, hypertension, diabetes, and gastrointestinal disorders. Absence of Mental or Psychological Illnesses: Participants should be free from any mental or psychological illnesses. Not Pregnant or Breastfeeding: Participants should not be pregnant or breastfeeding. Participants are required to adhere to the prescribed caloric intake, with total caloric intake falling below 80% or exceeding 110% of the recommended amount. 18 years 50 years Female Patients who may be diagnosed with hypertension, diabetes, heart disease, or gastrointestinal disorders during the study will be excluded to maintain the homogeneity of the study population and to prevent the confounding influence of newly developed health conditions on the study outcomes. Individuals who do not adhere to the prescribed caloric intake (defined as total caloric intake falling below 80% or exceeding 110% of the recommended amount) will be excluded due to the potential for this to compromise the integrity of the intervention and the validity of the results. Lost to Follow-Up/Unwilling to Continue: Participants who are lost to follow-up and are unwilling to continue the study will be excluded as they cannot provide complete data for analysis. Smoking has a profound impact on inflammation, oxidative stress, and metabolic function. To avoid confounding effects related to smoking, current smokers will be excluded. Individuals with a history of eating disorders (e.g., anorexia nervosa, bulimia nervosa) will be excluded due to the potential for these conditions to influence adherence to the dietary interventions and to confound the psychological and physiological outcomes of the study. Prevention Participants will adhere to a prescribed diet for 12 weeks, tailored to their group and daily energy requirements, which are calculated using the Mifflin equation. The FD diet (5:2 intermittent fasting protocol) involves two fasting days per week, during which participants consume only 25% of their recommended caloric intake, and five feeding days, where they consume 100% of their calculated daily energy requirements across three main meals and three snacks. Feeding times are standardized: breakfast at 8:00, lunch at 13:00, dinner at 20:00, with snacks at 10:00, 16:00, and 22:00. The control group consumes 80% of their daily energy requirement with the same meal and snack schedule. Both groups follow these dietary plans for 12 weeks, with daily macronutrient distribution set at 55% carbohydrates, 30% fat, and 15% protein. Participants are monitored for any adverse effects, which are reported to the research staff, and no physical or psychological harm is anticipated from the study. Waist circumference. Timepoint: The beginning and end of the study. Method of measurement: using nonstretchable (flexible) tape measure. Mid-upper arm circumference. Timepoint: The beginning and end of the study. Method of measurement: Non-elastic tape measure. Forearm circumference. Timepoint: The beginning and end of the study. Method of measurement: Non-elastic tape measure. Calf circumference. Timepoint: The beginning and end of the study. Method of measurement: Non-elastic tape measure. Total cholesterol. Timepoint: The beginning and end of the study. Method of measurement: Enzymatic method. Triglycerides. Timepoint: The beginning and end of the study. Method of measurement: Triglyceride oxidase. High-density lipoprotein. Timepoint: The beginning and end of the study. Method of measurement: Fasting blood HDL cholesterol is measured in the laboratory. Low-density lipoprotein. Timepoint: The beginning and end of the study. Method of measurement: Fasting blood LDL cholesterol is measured in the laboratory. Fasting plasma glucose. Timepoint: The beginning and end of the study. Method of measurement: The fasting blood Glucose level determined in laboratory. Body Mass Index. Timepoint: The beginning and end of the study. Method of measurement: Height: stadiometer, Weight: scale. Waist-hip ratio. Timepoint: The beginning and end of the study. Method of measurement: standard formula. Visceral fat area. Timepoint: The beginning and end of the study. Method of measurement: standard formula. Body fat percentage. Timepoint: The beginning and end of the study. Method of measurement: standard formula. Hip circumference. Timepoint: The beginning and end of the study. Method of measurement: using nonstretchable (flexible) tape measure. C-reactive protein. Timepoint: The beginning and end of the study. Method of measurement: Pars Azmoon commercial kit. Interleukin-1. Timepoint: The beginning and end of the study. Method of measurement: ELISA method. Monocyte chemoattractant protein-1. Timepoint: The beginning and end of the study. Method of measurement: ELISA method. Irisin. Timepoint: The beginning and end of the study. Method of measurement: ELISA method. Lipocalin 2. Timepoint: The beginning and end of the study. Method of measurement: ELISA method. Alanine Aminotransferase. Timepoint: The beginning and end of the study. Method of measurement: SGPT. AST. Timepoint: The beginning and end of the study. Method of measurement: SGOT. Waist-to-hip ratio. Timepoint: The beginning and end of the study. Method of measurement: standard formula. National Institute for Medical Research Development(NIMAD) Approved 2025-05-04 Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee 5 km Qutb Ravandi Boulevard, Kashan University of Medical Sciences, Vice Chancellor for Research Kashan Isfehan Iran (Islamic Republic of)