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

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:

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.

Target sample size: 50