The effect of probiotics supplementation on cognitive function and BDNF in patients with type 2 diabetes
Design
double blind randomized controlled trial
Settings and conduct
84 patients with type 2 diabetes 45-65 years old referred to Rasoul Akram Hospital and randomly assigned to either intervention or placebo groups (8 weeks). To measure fasting blood sugar, hemoglobin A1C, and serum BDNF, 10 ml of venous blood was collected after 10-12 hours of fasting at the beginning and end of the study. It will also be conducted to assess the cognitive performance of ACE and TMT cognitive tests at the end and end of the intervention.
Participants/Inclusion and exclusion criteria
1. Willingness to cooperate and complete informed consent
Type 2 diabetes according to the diagnosis of a specialist based on patient records
3. At least 2 years of history of type 2 diabetes
4. No change in the type and dose of medication taken 8 weeks before the intervention
5- Age 45-65
6. No use of probiotic-containing foods for the past 4 weeks
1- Cancer, severe liver and kidney disorders, heart failure and surgery and other endocrine disorders
2-Pregnancy and lactation and hormone-sensitive conditions
3. Use of liver-degrading, anticoagulant, and platelet-derived drugs
4- Use of antidepressants and other drugs that affect the nerves
5. Insulin injection
6- Pregnancy Pills
7. Recent dietary supplements (no case of taking calcium, vitamin D and group B routinely for the past 6 months)
8- Use of antibiotics for the past 1 month
9- Tobacco, drugs and alcohol
Intervention groups
Intervention group: 2 capsules of 500 mg Foam Locket daily
Control group: 2 capsules daily 500 mg placebo
Main outcome variables
cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090901002394N44
Registration date:2019-11-25, 1398/09/04
Registration timing:registered_while_recruiting
Last update:2019-11-25, 1398/09/04
Update count:0
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic supplementation on cognitive function and BDNF in patients with type 2 diabetes
Public title
Effect of probiotic supplementation in patients with type 2 diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate and signing informed consent
Having type 2 diabetes based on medical records
At least 2 years history of type 2 diabetes
No change in the type and dose of medication taken 8 weeks before the intervention
Age 45-65
Not eating probiotic-containing foods for the past 4 weeks
Exclusion criteria:
Cancer, severe liver and kidney disorders, heart failure and surgery and other endocrine disorders
Pregnancy and lactation and hormone-sensitive conditions
Use of liver, anticoagulant, and platelet-degrading drugs
Use of antidepressants and other drugs that affect the nerves
Insulin injection
Contraceptive use
Recent dietary supplements (no case if calcium - vitamin D and group B supplements are routinely consumed for the past 6 months)
Use of antibiotics for the past 1 month
Tobacco, drugs and alcohol
weight loss diet and weight changes over 5% in the last 3 months
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be divided into two groups using block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double-blind the study of total cans containing capsules by a person other than the researcher, the researcher and statistical consultant and physician will be unaware of this classification. These divisions are based on random number tables
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, next to Milad Hospital, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.IUMS.REC.1398.316
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
diabetes (mellitus)(nonobese)(obese): adult-onsetmaturity-onset nonketotic stable non-insulin-dependent diabetes of the young
Primary outcomes
1
Description
cognitive function
Timepoint
at baseline, and after 2 month
Method of measurement
Addenbrooke’s Cognitive Examination - Trail Making Test
2
Description
BDNF
Timepoint
at baseline, and after 2 month
Method of measurement
Eliza
Secondary outcomes
1
Description
physical activity
Timepoint
beginning and end of intervention
Method of measurement
IPAQ questionnaire
2
Description
energy intake
Timepoint
beginning and end of intervention
Method of measurement
Three-day food record
Intervention groups
1
Description
Intervention group: 2 capsules of 500mg familact daily for 12 weeks
Category
Treatment - Other
2
Description
Control group: Take 2 placebo capsules daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
hazraterasul hospital
Full name of responsible person
Dr amir ziyaee
Street address
Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
Jazayeri.sh@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevallian
Street address
تهران،بزرگراه همت، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
simakheradmand
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
sima.kherad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr shima jazayeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
sh_jazayeri@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
simakheradmand
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
sima.kherad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not 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
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
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document