Investigating the effect of modified psychobiotic diet on the severity of depression, anxiety and dietary related-reward systems in overweight/obese subjects with depression
Determining the effect of modified psychobiotic diet on the severity of depression, anxiety and brain reward systems related to food cravings in overweight and obese people with depression.
Design
A clinical trial with a control group, with parallel groups, without blinding, will be conducted randomly on 44 patients. Permuted block randomization is used for randomization.
(Since the type of intervention was the regime, there is no possibility of blinding.)
Settings and conduct
Sampling is Convenience and will be done in clinics. The relevant poster will be attached in the clinics of Imam Hospital and the applicants should complete questionnaires by scanning the QR code located in the poster. If the necessary criteria are met, we will call them by the number that they entered.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with mild to moderate depression, age 18 to 65 years and a body mass index of 25 to 35 exclusion criteria: history of a specific disease and the use of any medication and supplements that affect the microbiome.
Intervention groups
The intervention with the modified psychobiotic diet is carried out for 6 weeks. This diet means using foods effective on beneficial intestinal bacteria in the brain-intestinal axis.
This intervention in our plan is based on changing the dietary protein base of the person from animal protein to vegetable protein, adding fermented foods, increasing the percentage of dietary fiber and reducing foods that interfere with the gut microbiome, such as sweets, alcohol, and fast food.
The diet of control group is necessary recommendations for a healthier lifestyle.
Main outcome variables
Degree of Depression; Degree of anxiety; Food desire; Trimethylamine N-oxide
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015536N14
Registration date:2024-05-27, 1403/03/07
Registration timing:registered_while_recruiting
Last update:2024-05-27, 1403/03/07
Update count:0
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of modified psychobiotic diet on the severity of depression, anxiety and dietary related-reward systems in overweight/obese subjects with depression
Public title
Investigating the effect of modified psychobiotic diet on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have mild to moderate depression
18-65 years old
BMI 25-35
Exclusion criteria:
Have any special diet
Receiving antioxidant or omega 3 supplements within 6 weeks before starting the intervention
Taking psychotropic drugs, contraceptives, antibiotics, proton pump inhibitors, steroids, immunosuppressive drugs, and laxatives up to four weeks before the intervention.
Non-steroidal anti-inflammatory drugs > dose of 3 grams
History of kidney, liver, heart or respiratory disease, heart attack or stroke
Functional problems of the digestive system, chronic constipation
Smoking or tobacco use
Pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the groups, the permuted block randomization method is used. In this method, eligible people who meet the study entry criteria are selected and then randomly selected using 4 blocks, which are based on BMI (25-30 and 30-35). People will be randomly assigned to modified psychobiotic diet group or control group. In random assignment, in order to the list of numbers, the letters A and B of the patients codes will be determined. Numbers will be assigned to the patients in the order of the participants entry, and the patients will receive psychobiotic diet or control diet based on specific letters (A and B).
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 Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.026
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Depression score in Beck Questionnaire
Timepoint
Measurement of the depression score at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the modified psychobiotic diet.
Method of measurement
Beck Depression questionnaire
2
Description
Anxiety score in Beck questionnaire
Timepoint
Measurement of the Anxiety score at the beginning of the study (before the start of the intervention) and 6 weeks after the start of the modified psychobiotic diet.
Method of measurement
Beck Anxiety Questionnaire
3
Description
Food Addiction Score in the Yale Food Addiction Questionnaire
Timepoint
Measuring the food addiction score at the beginning of the study (before the intervention) and 6 weeks after the start of the modified psychobiotic diet.
Method of measurement
Yale Food Addiction Questionnaire
Secondary outcomes
1
Description
Trimethylamine-N oxide
Timepoint
The beginning of the study (before the start of the intervention) and 6 weeks after the start of psychobiotic diet
Method of measurement
Trimethylamine N-oxide kit (Zelbio )
2
Description
Leptin
Timepoint
The beginning of the study (before the start of the intervention) and 6 weeks after the start of the psychobiotic diet
Method of measurement
Leptin assay kit- Human
3
Description
Lipid profile
Timepoint
The beginning of the study (before the start of the intervention) and 6 weeks after the start of the psychobiotic diet
Method of measurement
Lipid profile assay laboratory kit
Intervention groups
1
Description
Intervention group: modified psychobiotic diet It uses foods that have effects on beneficial intestinal bacteria in the gut brain axis. 6 to 8 units per day of fruits and vegetables, one unit of nuts and seeds per day, 1 to 2 units of fermented products per day and 3 to 4 units of legumes per week should be consumed. Foods that interfere with the intestinal microbiome, such as sweets, alcohol and fast food, should be limited. The duration of the diet is 6 weeks.
Category
Treatment - Other
2
Description
Control group: common diet The diet of this group includes the usual nutritional recommendations for a healthy lifestyle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh Attar
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Fax
+98 21 6658 1625
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Sixth Floor, Central Building of Tehran University of Medical Science, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadjavad Hosseinzadeh Attar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No44, Hojat Dost Alley, Naderi St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5742
Email
Info_snsd@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad javad Hosseinzadeh Attar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No44, Hojat Dost Alley, Naderi St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5742
Email
Info_snsd@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh Attar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No44, Hojat Dost Alley, Naderi St, Keshavarz Blvd, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 5742
Email
Info_snsd@tums.ac.ir
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