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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Protocol summary
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. Because it is a diet intervention, it is not blinding. The trial phase is not applicable.
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.
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. Because it is a dietDue to the dietary nature of the intervention, itblinding is not blinding. Thefeasible.However, Laboratory staff, the statistician, and the anthropometric assessor will be blinded to group allocation.The trial phase is not applicable.
این یک کارآزمایی تصادفی، کنترل شده و گروهی موازی است. شرکت کنندگان با استفاده از تصادفی سازی طبقه ای بر اساس سن و BMI طبقه بندی خواهند شد. سپس با استفاده از جدول اعداد تصادفی به یکی از دو گروه مداخله و کنترل تخصیص داده می شوند. چون مداخله رژیم غذایی است، کورسازی ندارد. فاز کارآزمایی کاربرد ندارد.
این یک کارآزمایی تصادفی، کنترل شده و گروهی موازی است. شرکت کنندگان با استفاده از تصادفی سازی طبقه ای بر اساس سن و BMI طبقه بندی خواهند شد. سپس با استفاده از جدول اعداد تصادفی به یکی از دو گروه مداخله و کنترل تخصیص داده می شوند.با توجه به ماهیت رژیمی مداخله، کورسازی امکانپذیر نیست. اما کارکنان آزمایشگاه، آنالیزور آماری و ارزیاب آنتروپومتریک نسبت به تخصیص گروهی کور خواهند بود.فاز کارآزمایی کاربرد ندارد.
این یک کارآزمایی تصادفی، کنترل شده و گروهی موازی است. شرکت کنندگان با استفاده از تصادفی سازی طبقه ای بر اساس سن و BMI طبقه بندی خواهند شد. سپس با استفاده از جدول اعداد تصادفی به یکی از دو گروه مداخله و کنترل تخصیص داده می شوند. چونشوند.با توجه به ماهیت رژیمی مداخله رژیم غذایی است، کورسازی نداردامکانپذیر نیست. فازاما کارکنان آزمایشگاه، آنالیزور آماری و ارزیاب آنتروپومتریک نسبت به تخصیص گروهی کور خواهند بود.فاز کارآزمایی کاربرد ندارد.
General information
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2026-03-21, 1405/01/01
2026-03-21 00:00:00
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2026-07-21, 1405/04/30
2026-07-21 00:00:00
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The study information was updated to clarify and complete the registered protocol details.
The study information was updated to clarify and complete the registered protocol details.
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اطلاعات مطالعه به منظور شفافسازی و تکمیل جزئیات پروتکل ثبتشده بهروزرسانی شد.
اطلاعات مطالعه به منظور شفافسازی و تکمیل جزئیات پروتکل ثبتشده بهروزرسانی شد.
قد : استادیومتر، وزن: ترازومتر نواری غیر قابل ارتجاع
#2
waist-hip ratio
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waist-hip ratio
نسبت کمر به باسن
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نسبت کمر به باسن
The beginning and end of the study
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The beginning and end of the study
ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
standard formula
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standard formula
فرمولای استاندارد
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فرمولای استاندارد
#3
visceral fat area
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visceral fat area
ناحیه چربی احشایی
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ناحیه چربی احشایی
The beginning and end of the study
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The beginning and end of the study
ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
standard formula
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standard formula
فرمولای استاندارد
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فرمولای استاندارد
#4
body fat percentage
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body fat percentage
درصد چربی بدن
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درصد چربی بدن
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The beginning and end of the study
ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
standard formula
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standard formula
فرمولای استاندارد
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فرمولای استاندارد
#5
Waist circumference
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Waist circumference
دور کمر
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دور کمر
The beginning and end of the study
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
using nonstretchable (flexible) tape measure
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using nonstretchable (flexible) tape measure
متر نواری غیر قابل ارتجاع
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متر نواری غیر قابل ارتجاع
#6
Hip circumference
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Hip circumference
دور باسن
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دور باسن
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The beginning and end of the study
ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
using nonstretchable (flexible) tape measure
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using nonstretchable (flexible) tape measure
متر نواری غیر قابل ارتجاع
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متر نواری غیر قابل ارتجاع
#7
C-reactive protein
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C-reactive protein
پروتِیِن واکنشگرC
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پروتِیِن واکنشگرC
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
ELISA Method
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ELISA Method
روش ELISA
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روش ELISA
#8
interleukin-1
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interleukin-1
اینترلوکین1
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اینترلوکین1
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
ELISA method
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ELISA method
روش ELISA
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روش ELISA
#9
Monocyte chemoattractant protein-1
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Monocyte chemoattractant protein-1
پروتئین جاذب شیمیایی مونوسیت-۱
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پروتئین جاذب شیمیایی مونوسیت-۱
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
ELISA method
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ELISA method
روش ELISA
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روش ELISA
#10
irisin
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irisin
آیریزین
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آیریزین
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
ELISA method
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روش ELISA
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روش ELISA
#11
lipocalin 2
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lipocalin 2
لیپوکالین2
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لیپوکالین2
The beginning and end of the study
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
ELISA method
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ELISA method
روش ELISA
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روش ELISA
#12
Alanine Aminotransferase
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Alanine Aminotransferase
آلانین آمینوترانسفراز
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آلانین آمینوترانسفراز
The beginning and end of the study
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The beginning and end of the study
ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
SGPT
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SGPT
آزمایش ترانس آمیناز گلوماتیک – پیرویک سرم
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آزمایش ترانس آمیناز گلوماتیک – پیرویک سرم
#13
AST
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AST
آسپارتات آمینوترانسفراز
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آسپارتات آمینوترانسفراز
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
SGOT
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SGOT
گلوتامیک اگزالواستیک ترانسآمیناز
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گلوتامیک اگزالواستیک ترانسآمیناز
#14
waist-to-hip ratio
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waist-to-hip ratio
نسبت دور کمر به دور باسن
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نسبت دور کمر به دور باسن
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ابتدا و انتهای مطالعه
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ابتدا و انتهای مطالعه
Standard method
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Standard method
فرمول استاندارد
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فرمول استاندارد
Secondary outcomes
#1
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Body Mass Index
Body Mass Index
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شاخص توده بدنی
شاخص توده بدنی
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The beginning and end of the study
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ابتدا و انتهای مطالعه
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Height: stadiometer, Weight: scale
Height: stadiometer, Weight: scale
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قد : استادیومتر، وزن: ترازو
قد : استادیومتر، وزن: ترازو
#2
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waist-hip ratio
waist-hip ratio
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نسبت کمر به باسن
نسبت کمر به باسن
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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standard formula
standard formula
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فرمولای استاندارد
فرمولای استاندارد
#3
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visceral fat area
visceral fat area
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ناحیه چربی احشایی
ناحیه چربی احشایی
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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standard formula
standard formula
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فرمولای استاندارد
فرمولای استاندارد
#4
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body fat percentage
body fat percentage
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درصد چربی بدن
درصد چربی بدن
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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standard formula
standard formula
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فرمولای استاندارد
فرمولای استاندارد
#5
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Hip circumference
Hip circumference
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دور باسن
دور باسن
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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using nonstretchable (flexible) tape measure
using nonstretchable (flexible) tape measure
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متر نواری غیر قابل ارتجاع
متر نواری غیر قابل ارتجاع
#6
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C-reactive protein
C-reactive protein
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پروتِیِن واکنشگرC
پروتِیِن واکنشگرC
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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Pars Azmoon commercial kit
Pars Azmoon commercial kit
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کیت تجاری شرکت پارسآزمون
کیت تجاری شرکت پارسآزمون
#7
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interleukin-1
interleukin-1
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اینترلوکین1
اینترلوکین1
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
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ELISA method
ELISA method
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روش ELISA
روش ELISA
#8
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Monocyte chemoattractant protein-1
Monocyte chemoattractant protein-1
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پروتئین جاذب شیمیایی مونوسیت-۱
پروتئین جاذب شیمیایی مونوسیت-۱
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
ELISA method
ELISA method
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روش ELISA
روش ELISA
#9
empty
irisin
irisin
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آیریزین
آیریزین
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
ELISA method
ELISA method
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روش ELISA
روش ELISA
#10
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lipocalin 2
lipocalin 2
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لیپوکالین2
لیپوکالین2
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The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
ELISA method
ELISA method
empty
روش ELISA
روش ELISA
#11
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Alanine Aminotransferase
Alanine Aminotransferase
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آلانین آمینوترانسفراز
آلانین آمینوترانسفراز
empty
The beginning and end of the study
The beginning and end of the study
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
SGPT
SGPT
empty
آزمایش ترانس آمیناز گلوماتیک – پیرویک سرم
آزمایش ترانس آمیناز گلوماتیک – پیرویک سرم
#12
empty
AST
AST
empty
آسپارتات آمینوترانسفراز
آسپارتات آمینوترانسفراز
empty
The beginning and end of the study
The beginning and end of the study
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ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
SGOT
SGOT
empty
گلوتامیک اگزالواستیک ترانسآمیناز
گلوتامیک اگزالواستیک ترانسآمیناز
#13
empty
waist-to-hip ratio
waist-to-hip ratio
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نسبت دور کمر به دور باسن
نسبت دور کمر به دور باسن
empty
The beginning and end of the study
The beginning and end of the study
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
standard formula
standard formula
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فرمولای استاندارد
فرمولای استاندارد
Recruitment centers
#1
Name of recruitment center - English: Kashan Health Centers
Name of recruitment center - Persian: مراکز بهداشت کاشان
Full name of responsible person - English: Sadegh Jafarnejad
Full name of responsible person - Persian: صادق جعفرنژاد
Street address - English: کیلومتر پنجم بلوار قطب راوندی
Street address - Persian: 5th of Qotb –e Ravandi Blvd.
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 21 5544 7275
Fax: +98 21 5544 2061
Email: darman@at_kaums.ac.ir
Web page address: http://contact.kaums.ac.ir/Default.aspx
Name of recruitment center - English: Kashan Health Centers
Name of recruitment center - Persian: مراکز بهداشت کاشان
Full name of responsible person - English: Sadegh Jafarnejad
Full name of responsible person - Persian: صادق جعفرنژاد
Street address - English: کیلومتر پنجم بلوار قطب راوندی
Street address - Persian: 5th of Qotb –e Ravandi Blvd.
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 21 5544 7275
Fax: +98 21 5544 2061
Email: drsadegh2008@gmail.com
Web page address: http://contact.kaums.ac.ir/Default.aspx
Name of recruitment center - English: Kashan Health Centers Name of recruitment center - Persian: مراکز بهداشت کاشان Full name of responsible person - English: Sadegh Jafarnejad Full name of responsible person - Persian: صادق جعفرنژاد Street address - English: کیلومتر پنجم بلوار قطب راوندی Street address - Persian: 5th of Qotb –e Ravandi Blvd. City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715973474 Phone: +98 21 5544 7275 Fax: +98 21 5544 2061 Email: darmandrsadegh2008@at_kaums.ac.irgmail.com Web page address: http://contact.kaums.ac.ir/Default.aspx
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sadegh Jafarnejad
Full name of responsible person - Persian: صادق جعفرنژاد
Street address - English: کیلومتر پنجم بلوار قطب راوندی
Street address - Persian: 5th of Qotb –e Ravandi Blvd.
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 1112
Fax: +98 31 5554 1112
Email: banafshe57@hotmail.com
Web page address: http://en.kaums.ac.ir/Default.aspx?PageID=199
contact.organization_id:
Name of organization / entity - English: National Institute for Medical Research Development(NIMAD)
Name of organization / entity - Persian: مؤسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران (نیماد)
Full name of responsible person - English: Sadegh Jafarnejad
Full name of responsible person - Persian: صادق جعفرنژاد
Street address - English: کیلومتر پنجم بلوار قطب راوندی
Street address - Persian: 5th of Qotb –e Ravandi Blvd.
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 1112
Fax: +98 31 5554 1112
Email: banafshe57@hotmail.com
Web page address: http://en.kaums.ac.ir/Default.aspx?PageID=199
contact.organization_id: Name of organization / entity - English: National Institute for Medical Research Development(NIMAD) Name of organization / entity - Persian: مؤسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران (نیماد) Full name of responsible person - English: Sadegh Jafarnejad Full name of responsible person - Persian: صادق جعفرنژاد Street address - English: کیلومتر پنجم بلوار قطب راوندی Street address - Persian: 5th of Qotb –e Ravandi Blvd. City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 1112 Fax: +98 31 5554 1112 Email: banafshe57@hotmail.com Web page address: http://en.kaums.ac.ir/Default.aspx?PageID=199
Kashan University of Medical Sciences
National Institute for Medical Research Development(NIMAD)
Kashan University ofNational Institute for Medical SciencesResearch Development(NIMAD)
دانشگاه علوم پزشکی کاشان
مؤسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران (نیماد)
دانشگاهمؤسسه ملی توسعه تحقیقات علوم پزشکی کاشانجمهوری اسلامی ایران (نیماد)
Protocol summary
Study aim
Examining the Impact of Fast Diet and Calorie Deficit Diet on Emerging Adipokines Lipocalin 2, Irisin, and Inflammatory Markers among Women with Obesity/Overweight
Design
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.
Settings and conduct
Participants are selected from the Health Centers of Kashan University of Medical Sciences by convenient sampling. Participants are randomly assigned into two groups.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
BMI, waist-hip ratio, visceral fat area, body fat percentage, Waist circumference, C-reactive protein , interleukin-1, MCP-1, irisin, lipocalin 2
General information
Reason for update
The study information was updated to clarify and complete the registered protocol details.
Acronym
IRCT registration information
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
Registration date
2025-10-22, 1404/07/30
Registrant information
Name
Saeedeh Hosseini hooshiar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9024
Email address
shoseinih3322@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-21, 1405/01/01
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
2026-03-21, 1405/01/01
Actual recruitment end date
2026-07-21, 1405/04/30
Trial completion date
empty
Scientific title
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
Public title
The Impact of Fast Diet on Lipocalin 2, Irisin, and Inflammatory Markers
Purpose
Prevention
Inclusion/Exclusion 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:
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.
Age
From 18 years old to 50 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee
Street address
5 km Qutb Ravandi Boulevard, Kashan University of Medical Sciences, Vice Chancellor for Research
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2025-05-04, 1404/02/14
Ethics committee reference number
IR.NIMAD.REC.1404.028
Health conditions studied
1
Description of health condition studied
Obesity or overweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Waist circumference
Timepoint
The beginning and end of the study
Method of measurement
using nonstretchable (flexible) tape measure
Secondary outcomes
1
Description
Mid-upper arm circumference
Timepoint
The beginning and end of the study
Method of measurement
Non-elastic tape measure
2
Description
Forearm circumference
Timepoint
The beginning and end of the study
Method of measurement
Non-elastic tape measure
3
Description
calf circumference
Timepoint
The beginning and end of the study
Method of measurement
Non-elastic tape measure
4
Description
total cholesterol
Timepoint
The beginning and end of the study
Method of measurement
Enzymatic method
5
Description
triglycerides
Timepoint
The beginning and end of the study
Method of measurement
Triglyceride oxidase
6
Description
high-density lipoprotein
Timepoint
The beginning and end of the study
Method of measurement
Fasting blood HDL cholesterol is measured in the laboratory.
7
Description
low-density lipoprotein
Timepoint
The beginning and end of the study
Method of measurement
Fasting blood LDL cholesterol is measured in the laboratory.
8
Description
fasting plasma glucose
Timepoint
The beginning and end of the study
Method of measurement
The fasting blood Glucose level determined in laboratory
9
Description
Body Mass Index
Timepoint
The beginning and end of the study
Method of measurement
Height: stadiometer, Weight: scale
10
Description
waist-hip ratio
Timepoint
The beginning and end of the study
Method of measurement
standard formula
11
Description
visceral fat area
Timepoint
The beginning and end of the study
Method of measurement
standard formula
12
Description
body fat percentage
Timepoint
The beginning and end of the study
Method of measurement
standard formula
13
Description
Hip circumference
Timepoint
The beginning and end of the study
Method of measurement
using nonstretchable (flexible) tape measure
14
Description
C-reactive protein
Timepoint
The beginning and end of the study
Method of measurement
Pars Azmoon commercial kit
15
Description
interleukin-1
Timepoint
The beginning and end of the study
Method of measurement
ELISA method
16
Description
Monocyte chemoattractant protein-1
Timepoint
The beginning and end of the study
Method of measurement
ELISA method
17
Description
irisin
Timepoint
The beginning and end of the study
Method of measurement
ELISA method
18
Description
lipocalin 2
Timepoint
The beginning and end of the study
Method of measurement
ELISA method
19
Description
Alanine Aminotransferase
Timepoint
The beginning and end of the study
Method of measurement
SGPT
20
Description
AST
Timepoint
The beginning and end of the study
Method of measurement
SGOT
21
Description
waist-to-hip ratio
Timepoint
The beginning and end of the study
Method of measurement
standard formula
Intervention groups
1
Description
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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Health Centers
Full name of responsible person
Sadegh Jafarnejad
Street address
کیلومتر پنجم بلوار قطب راوندی
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 21 5544 7275
Fax
+98 21 5544 2061
Email
drsadegh2008@gmail.com
Web page address
http://contact.kaums.ac.ir/Default.aspx
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development(NIMAD)
Full name of responsible person
Sadegh Jafarnejad
Street address
کیلومتر پنجم بلوار قطب راوندی
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
banafshe57@hotmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development(NIMAD)
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadegh Jafarnejad
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
drsadegh2008@gmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadegh Jafarnejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
drsadegh2008@gmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini Hooshiar
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Email
shoseinih3322@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after making participants anonymous.
When the data will become available and for how long
Six months after publishing results, everything will be accessible.
To whom data/document is available
The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
What processes are involved for a request to access data/document
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.