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The effect of time restricted eating on cognitive function in men with metabolic syndrome: a randomized controlled trial

Protocol summary

Study aim
Investigating the effect of time restriction of eating for ten hours on the cognitive performance of men with metabolic syndrome
Design
Clinical trial with control group, with parallel groups, without blinding, simple randomization, using sealed envelopes and random numbers using sealed envelopes, on 40 patients.
Settings and conduct
Study subjects will be randomly selected from participants in the Mashhad-Persian Cohort who have metabolic syndrome. People will start doing cognitive tests with a single computer system in a special room . The Wisconsin test and go/nogo will be taught to people first, then in turn. The tests mentioned at the end of the study (week 6) will also be repeated. After completing the tests , depending on whether the person was placed in the intervention or control group, they will be given explanations about the diet. In the intervention group, people will receive food in a 10-hour period between 6 am and 8 pm.
Participants/Inclusion and exclusion criteria
Inclusion criteria: men between the ages of 18 and 65 years specific work and sleep schedule daily food intake more than 14 hours diagnosis of metabolic syndrome Exclusion criteria: diabetes thyroid disorders cancer diagnosed sleep disorder diagnosed cognitive disorders
Intervention groups
People in the intervention group will be selected from patients with metabolic syndrome. They will receive in a period of 10 hours. The control group has a diet with no time limit.
Main outcome variables
changes in eating inhibition behavior resulting from the

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230820059191N1
Registration date: 2023-08-22, 1402/05/31
Registration timing: prospective

Last update: 2023-08-22, 1402/05/31
Update count: 0
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
Mohammad Masoumvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2257 0530
Email address
masoumvandm4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of time restricted eating on cognitive function in men with metabolic syndrome: a randomized controlled trial
Public title
The effect of time restricted eating on cognitive function in men with metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged between 18 and 65 years, defined work and sleep schedule more than 14 hours of daily intake diagnosis of metabolic syndrome according to the International Diabetes Federation (IDF) definition mild to moderate activity level according to the IPAQ questionnaire
Exclusion criteria:
Diabetes thyroid disorders based on thyroid tests or thyroxine intake eating disorders serious diseases that affect food intake such as cancer inability to follow a time-limited meal plan sleep disorder diagnosed by a psychiatrist or psychologist known disorders Psychology or psychiatry that affect the quality of sleep (anxiety, depression, stress) use of drugs that change the quality or pattern of sleep (sedative and sleep-inducing drugs, stimulant drugs). Drugs that take dopamine agonist drugs, procyclidine, primidone, valproic acid, olanzapine, topiramate, gabapentin, fluoxetine, sertraline, quetiapine, and trazodone.
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: using sealed envelopes in a container that according to the sample size, 20 with control text and 20 with intervention text, which the participant will randomly choose.
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 Sciences
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad Campus, Mashhad University of Medical Sciences, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-06-13, 1402/03/23
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.242

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Changes in eating inhibition behavior resulting from go/no go test scores
Timepoint
The beginning of the study and the end of the sixth week
Method of measurement
go/nogo cognitive test

Secondary outcomes

1

Description
Changes in cognitive flexibility
Timepoint
The beginning of the study and the end of the sixth week
Method of measurement
Wisconsin cognitive Test

2

Description
Active memory changes
Timepoint
The beginning of the study and the end of the sixth week
Method of measurement
Wisconsin cognitive Test

Intervention groups

1

Description
Intervention group: In the intervention group, people will receive food in a period of 10 hours. It is recommended that this period be between 6 am and 8 pm. All foods and drinks except water, tea and coffee without added sweeteners should be consumed during this period. Due to not affecting the quality of sleep, tea and coffee consumption is allowed before 8 pm. With the help of researchers, participants will choose the best time frame that fits their life schedule. The patients' diet is according to their taste and freely, and there are no food restrictions. Participants will be explained about a healthy diet based on national dietary recommendations.
Category
Lifestyle

2

Description
Control group: The control group will have a diet without time limit and will receive the necessary recommendations about a healthy diet based on national dietary guidelines. In this group, the diet of the patients is according to their taste and freely, and there are no food restrictions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Cohort Center
Full name of responsible person
Mohsen Nematy
Street address
Imam Reza Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2000
Email
cohort@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
University St., facing 18 University, Qorshi Building, Research Vice-Chancellor of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
GhayourM@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
Mohammad Masoumvand
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Faculty of Medicine, Department of Nutrition
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
masoumvandm4001@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Nematy
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Faculty of Medicine, Department of Nutrition
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
NematyM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Masoumvand
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Azadi Square, East Gate of Ferdowsi University of Mashhad, Faculty of Medicine, Department of Nutrition
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
masoumvandm4001@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
Not applicable
Title and more details about the data/document
Only part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
Data access will start 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions and people working in industry if action is taken.
Under which criteria data/document could be used
The conditions of using non-identifiable data or other research achievements will be reviewed on a case-by-case basis after sending an official request by the Faculty of Medical Sciences.
From where data/document is obtainable
Dr. Mohsen Nemati Address: Mashhad, Azadi Square, East Gate of Ferdowsi University Campus, Mashhad University of Medical Sciences, Faculty of Medicine, Department of Nutrition Postal Code: 9177948564 Email: NematyM@mums.ac.ir Phone: 0098 51 38827034
What processes are involved for a request to access data/document
The applicant must send the data request with details via e-mail, and the request will be provided to the applicant after it is reviewed by the researchers and Mashhad University of Medical Sciences and if approved.
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