The Effect of Fasting and Ketogenic Diet Compared to Balanced Low-Calorie Diet on Weight among Obese Individuals with Eating Disorders: A Randomized Clinical Trial
Investigating the effect of two types of fasting diet, ketogenic and standard diet on anthropometric indicators, body composition, brain-derived neurotrophic factor (BDNF) and serotonin levels in obese people with eating disorders
Design
Allocation to 3 study groups is done randomly
The study is of parallel type
And the sample size is 75 people
Blinding is not possible due to the type of intervention, which is a treatment regimen
Settings and conduct
Sampling will be done in Tehran and will be selected from among the patients referred to the obesity center of Hazrat Fatemeh Al-Zahra Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Body mass index between 30 and 39.9 kg/m2
Willingness to participate in the study
Being in the age range of 20-60 years
Non-entry criteria:
Suffering from any disease such as cancer, diagnosed diabetes, hypothyroidism, kidney or liver failure.
Having a weight loss diet in the last 2 months
Pregnancy and breastfeeding
Menopause
smoking
Taking vitamin and mineral supplements
Continuous use of any type of medicine
Use of any type of antibiotic in the last three months
Using probiotic products (probiotic supplement, yogurt and probiotic cheese) continuously (more than once a week) in the last month
Use of weight loss and appetite suppressants
Having a sports activity that has been more than 3 weeks since its start.
Intervention groups
Recipient of a balanced low-calorie diet
Low calorie ketogenic diet recipient
Recipient of low-calorie fasting diet
Main outcome variables
Weight
BDNF serum level
Serotonin serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240629062275N1
Registration date:2024-07-21, 1403/04/31
Registration timing:prospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
maryam mohamadinarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4416 2494
Email address
maryam.mohamadi.narab@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2025-10-02, 1404/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fasting and Ketogenic Diet Compared to Balanced Low-Calorie Diet on Weight among Obese Individuals with Eating Disorders: A Randomized Clinical Trial
Public title
Effect of Different Types of Diet on Weight among Obese Individuals with Eating Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index between 30 and 39.9 kg/m2
Willingness to participate in the study
Being in the age range of 20-60 years
Exclusion criteria:
Suffering from any Disease such as Cancer, Diabetes, Hypothyroidism, Kidney Failure or Liver Failure
Having a weight loss diet in the last 2 months
Pregnancy and breastfeeding
Menopause
Smoking
Taking vitamin and mineral supplements
Continuous use of any type of medicine
Use of any type of antibiotic in the last three months
Using probiotic products continuously (more than once a week) in the last month
Use of weight loss and appetite suppressants
Having a sports activity that has been more than 3 weeks since its start
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Blocked Randomization is used to randomly assign people to three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-01-02, 1402/10/12
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.480
Health conditions studied
1
Description of health condition studied
A broad group of psychological disorders with abnormal eating behaviors leading to physiological effects from overeating or insufficient food intake.
ICD-10 code
F50
ICD-10 code description
Eating disorders
Primary outcomes
1
Description
weight
Timepoint
The beginning and end of the study
Method of measurement
Using a scale
Secondary outcomes
1
Description
Serum level of BDNF, serotonin
Timepoint
The beginning and end of the study
Method of measurement
Using a blood test
Intervention groups
1
Description
Intervention group 1: Participants who Received Fasting Diet
Category
Lifestyle
2
Description
Intervention group 2: Participants who Received Ketogenic Diet
Category
Lifestyle
3
Description
Control group: Participants who Received Balanced Low- Calorie Diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatima Al-Zahra Hospital
Full name of responsible person
Somaye Mokhber
Street address
yousef Abad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Safarian
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 1843 9490
Email
mjms@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Safarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2480
Email
SafarianM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Safarian
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2480
Email
SafarianM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr.mohammad Safarian
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Square, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3800 2480
Email
SafarianM@mums.ac.ir
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
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
Title and more details about the data/document
Data used in statistical analysis will be published without names of individuals
When the data will become available and for how long
Access will start from 2025
To whom data/document is available
All interested people
Under which criteria data/document could be used
Theses and articles are published in the form of files and printed copies
From where data/document is obtainable
Library of Mashhad University of Medical Sciences
The site of the magazine where the article is published
What processes are involved for a request to access data/document
After publishing the data in the appendix of the thesis and also the published articles, it will be accessible by applying to the university or visiting the journal website or even emailing the author responsible for the data.