Effect of time-restricted eating (TRE) or modified alternate day fasting (MADF) diet in comparison with calorie-restricted balanced diet on metabolic and hormonal indices in overweight/obese women with polycystic ovary syndrome
Determining the effect of time-restricted diet (TRE) and modified intermittent fasting (MADF) diet compared to a balanced diet with calorie restriction on metabolic and hormonal indicators in overweight and obese women with polycystic ovary syndrome
Design
Randomized controlled clinical trial, with parallel groups
Settings and conduct
In this 14-week clinical trial, 216 obese and overweight women referred to the Nutrition and Diet Therapy Clinic of Imam Reza Hospital with a diagnosis of polycystic ovary syndrome will be included in the study using a convenience sampling method and randomly assigned to three groups with an allocation ratio of 1:1:1. This will be done using opaque sealed envelopes to conceal the allocation process.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Body mass index of 25 kg/m2 and above
Diagnosis of polycystic ovary syndrome by a gynecologist
Age of 18 to 40 years
Exclusion criteria:
Pregnancy and breastfeeding
Menopause
Use of dietary supplements, diuretics, or laxatives during the intervention period
Participation in sports programs or changes in physical activity
Use of weight-affecting medications
Intervention groups
Time-restricted eating group: Participants are instructed to consume their diet ad libitum over 8 hours, and they are allowed to consume only calorie-free foods, non-starchy vegetables, and sugar-free gum from 7 p.m. to 11 a.m.
Modified intermittent fasting diet group: Participants are asked to consume a very low-calorie diet for 3 days and can eat ad libitum on the remaining days.
Control group: Participants consume their energy intake (500 kcal less than resting energy) according to a traditional substitution-based meal-list pattern, with breakfast, lunch, dinner, and two snacks.
Main outcome variables
Anthropometric indices and body composition analysis, hormonal indices, and glucose metabolism indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161022030424N14
Registration date:2025-06-14, 1404/03/24
Registration timing:prospective
Last update:2025-06-14, 1404/03/24
Update count:0
Registration date
2025-06-14, 1404/03/24
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-07-21, 1404/04/30
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of time-restricted eating (TRE) or modified alternate day fasting (MADF) diet in comparison with calorie-restricted balanced diet on metabolic and hormonal indices in overweight/obese women with polycystic ovary syndrome
Public title
Time-restricted eating (TRE) or modified alternate day fasting (MADF) diet in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index of 25 kg/m2 and above
Diagnosis of polycystic ovary syndrome by a gynecologist
Age between 18 tp 40 years
Exclusion criteria:
Pregnancy and breastfeeding
Menopause
Daily calorie intake of less than 800 and more than 4200 kcal
Use of dietary supplements, diuretics, or laxatives during the intervention period
Participation in sports programs or changes in physical activity
Use of weight-affecting medications
A deviation from a specific eating pattern due to medical or other reasons
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a stratified block randomization method for allocation. The computer-generated code generated using SAS software version 8.01 will be used to create a randomized sequence by a statistician outside the project's research team. Randomization will be stratified based on age and body mass index. Serially numbered opaque sealed packets will be used to ensure allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding the patients is not feasible in this trial. A trained nutritionist will ban diet-related conversations between assessors and patients during the study. Outcome assessors and the person responsible for statistical analysis will be blinded to the type of interventions received until the end of the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5456787654
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.TBZMED.REC.1404.218
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Free androgen index (FAI)
Timepoint
Measurement of Free androgen index (FAI) at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
It is calculated by dividing the numerical value of serum free testosterone by the value of sex hormone-binding globulin.
Secondary outcomes
1
Description
Weight
Timepoint
Weight measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Seca digital scale
2
Description
Body fat mass
Timepoint
Body fat mass measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Body analyzer
3
Description
Prolactin levels
Timepoint
Prolactin level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
4
Description
Total testosterone level
Timepoint
Total testosterone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
5
Description
luteinizing hormone level
Timepoint
luteinizing hormone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
6
Description
Follicle-stimulating hormone level
Timepoint
Follicle-stimulating hormone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
7
Description
Sex hormone-binding globulin level
Timepoint
Sex hormone-binding globulin level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
8
Description
Serum indicators of glucose metabolism
Timepoint
Serum indicators of glucose metabolism measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
9
Description
Progesterone levels
Timepoint
Progesterone level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
10
Description
Estrogen levels
Timepoint
Estrogen level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
11
Description
Dehydroepiandrosterone sulfate level
Timepoint
Dehydroepiandrosterone sulfate level measurement at the beginning of the study (before the start of the intervention) and 14 weeks after the start of the intervention
Method of measurement
Biochemical analysis
Intervention groups
1
Description
Time-restricted eating group: Participants are instructed to consume their diet ad libitum over 8 hours, and they are allowed to consume only calorie-free foods, non-starchy vegetables, and sugar-free gum from 7 p.m. to 11 a.m.
Category
Treatment - Other
2
Description
Modified intermittent fasting diet group: Participants are asked to consume a very low-calorie diet for 3 days and can eat ad libitum on the remaining days.
Category
Treatment - Other
3
Description
Control group: Participants consume their energy intake (500 kcal less than resting energy) according to a traditional substitution-based meal-list pattern, with breakfast, lunch, dinner, and two snacks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational and Medical Center
Full name of responsible person
Neda Dolatkhah
Street address
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
neda_dolatkhah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosro Adibkia
Street address
Vice Chancellor for Research and Technology, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5456765432
Phone
+98 41 3334 7054
Email
adibkia@tbzmed.ac.ir
Grant name
Grant code / Reference number
75863
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
neda_dolatkhah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
neda_dolatkhah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
neda_dolatkhah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available