Obesity or overweight.
Conditions
Interventions
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 fastin
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist-to-hip ratio. Timepoint: The beginning and end of the study. Method of measurement: Standard method.;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.;Waist circumference. Timepoint: The beginning and end of the study. Method of measurement: using nonstretchable (flexible) tape measure.;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: ELISA Method.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSadegh Jafarnejad
Kashan University of Medical Sciences
Outcome results
None listed