Protocol summary
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Study aim
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Examining the Impact of Fast Diet and Calorie Deficit Diet on Emerging Adipokines Lipocalin 2, Irisin, and Inflammatory Markers among Women with Obesity/Overweight
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Design
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This is a randomized, controlled, parallel-group trial. Participants will be stratified using stratified randomization based on age and BMI. Then using the random numbers table are assigned to one of the two groups intervention and control. Due to the dietary nature of the intervention, blinding is not feasible.However, Laboratory staff, the statistician, and the anthropometric assessor will be blinded to group allocation.The trial phase is not applicable.
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Settings and conduct
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Participants are selected from the Health Centers of Kashan University of Medical Sciences by convenient sampling. Participants are randomly assigned into two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
Women aged 18–50 years with BMI 25–40 kg/m², not following specific diets or using weight-loss medications/supplements, without chronic or psychological illnesses, and not pregnant or breastfeeding.
Exclusion Criteria:
Those with hypertension, diabetes, heart, or gastrointestinal diseases; smokers; individuals with eating disorders; or those non-adherent or lost to follow-up.
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Intervention groups
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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 and follow these dietary plans for 12 weeks.
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Main outcome variables
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BMI, waist-hip ratio, visceral fat area, body fat percentage, Waist circumference, C-reactive protein , interleukin-1, MCP-1, irisin, lipocalin 2
General information
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Reason for update
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The study information was updated to clarify and complete the registered protocol details.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220522054958N4
Registration date:
2025-10-22, 1404/07/30
Registration timing:
prospective
Last update:
2026-10-06, 1405/07/14
Update count:
1
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Registration date
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2025-10-22, 1404/07/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-03-21, 1405/01/01
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Expected recruitment end date
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2027-03-21, 1406/01/01
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Actual recruitment start date
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2026-03-21, 1405/01/01
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Actual recruitment end date
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2026-07-21, 1405/04/30
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The Impact of Fast Diet on Lipocalin 2, Irisin, and Inflammatory Markers
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
Actual sample size reached:
47
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2025-05-04, 1404/02/14
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Ethics committee reference number
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IR.NIMAD.REC.1404.028
Health conditions studied
1
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Description of health condition studied
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Obesity or overweight
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Waist circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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using nonstretchable (flexible) tape measure
Secondary outcomes
1
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Description
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Mid-upper arm circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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Non-elastic tape measure
2
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Description
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Forearm circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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Non-elastic tape measure
3
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Description
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calf circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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Non-elastic tape measure
4
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Description
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total cholesterol
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Timepoint
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The beginning and end of the study
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Method of measurement
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Enzymatic method
5
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Description
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triglycerides
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Timepoint
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The beginning and end of the study
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Method of measurement
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Triglyceride oxidase
6
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Description
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high-density lipoprotein
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Timepoint
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The beginning and end of the study
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Method of measurement
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Fasting blood HDL cholesterol is measured in the laboratory.
7
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Description
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low-density lipoprotein
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Timepoint
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The beginning and end of the study
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Method of measurement
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Fasting blood LDL cholesterol is measured in the laboratory.
8
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Description
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fasting plasma glucose
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Timepoint
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The beginning and end of the study
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Method of measurement
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The fasting blood Glucose level determined in laboratory
9
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Description
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Body Mass Index
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Timepoint
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The beginning and end of the study
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Method of measurement
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Height: stadiometer, Weight: scale
10
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Description
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waist-hip ratio
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Timepoint
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The beginning and end of the study
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Method of measurement
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standard formula
11
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Description
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visceral fat area
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Timepoint
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The beginning and end of the study
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Method of measurement
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standard formula
12
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Description
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body fat percentage
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Timepoint
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The beginning and end of the study
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Method of measurement
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standard formula
13
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Description
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Hip circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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using nonstretchable (flexible) tape measure
14
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Description
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C-reactive protein
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pars Azmoon commercial kit
15
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Description
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interleukin-1
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA method
16
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Description
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Monocyte chemoattractant protein-1
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA method
17
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Description
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irisin
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA method
18
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Description
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lipocalin 2
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA method
19
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Description
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Alanine Aminotransferase
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Timepoint
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The beginning and end of the study
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Method of measurement
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SGPT
20
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Description
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AST
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Timepoint
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The beginning and end of the study
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Method of measurement
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SGOT
21
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Description
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waist-to-hip ratio
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Timepoint
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The beginning and end of the study
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Method of measurement
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standard formula
Intervention groups
1
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Institute for Medical Research Development(NIMAD)
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data can be shared after making participants anonymous.
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When the data will become available and for how long
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Six months after publishing results, everything will be accessible.
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To whom data/document is available
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The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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