Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with Alzheimer's disease
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Golabchi Welfare Organization
Name of recruitment center - Persian: سازمان بهزیستی گلابچی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Naghavi ClinicGolabchi Welfare Organization Name of recruitment center - Persian: کلینیک نقویسازمان بهزیستی گلابچی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
#2
Name of recruitment center - English: Shayestegan Welfare Organization
Name of recruitment center - Persian: سازمان بهزیستی شایستگان
Full name of responsible person - English: Reza Heidari-Soureshjani
Full name of responsible person - Persian: رضا حیدری سورشجانی
Street address - English: Shahrekord- Isar street
Street address - Persian: شهرکرد-خیابان ایثار
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8817945611
Phone: +98 31 5546 3378
Fax:
Email: heidari.reza1995@gmail.com
Web page address:
Name of recruitment center - English: Shayestegan Welfare Organization Name of recruitment center - Persian: سازمان بهزیستی شایستگان Full name of responsible person - English: Reza Heidari-Soureshjani Full name of responsible person - Persian: رضا حیدری سورشجانی Street address - English: Shahrekord- Isar street Street address - Persian: شهرکرد-خیابان ایثار City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8817945611 Phone: +98 31 5546 3378 Fax: Email: heidari.reza1995@gmail.com Web page address:
#3
Name of recruitment center - English: Madar Welfare Organization
Name of recruitment center - Persian: سازمان بهزیستی مادر
Full name of responsible person - English: Reza Heidari-Soureshjani
Full name of responsible person - Persian: رضا حیدری سورشجانی
Street address - English: Shahrekord-Abi Sq- 15th Alley
Street address - Persian: شهرکرد-میدان آبی- کوچه پانزدهم
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 5000690346018
Phone: +98 31 5546 3378
Fax:
Email: heidari.reza1995@gmail.com
Web page address:
Name of recruitment center - English: Madar Welfare Organization Name of recruitment center - Persian: سازمان بهزیستی مادر Full name of responsible person - English: Reza Heidari-Soureshjani Full name of responsible person - Persian: رضا حیدری سورشجانی Street address - English: Shahrekord-Abi Sq- 15th Alley Street address - Persian: شهرکرد-میدان آبی- کوچه پانزدهم City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 5000690346018 Phone: +98 31 5546 3378 Fax: Email: heidari.reza1995@gmail.com Web page address:
#4
Name of recruitment center - English: Amin Welfare Organization
Name of recruitment center - Persian: سازمان بهزیستی امین
Full name of responsible person - English: Reza Heidari-Soureshjani
Full name of responsible person - Persian: رضا حیدری سورشجانی
Street address - English: Shahrekord-Boroujen-siasard street
Street address - Persian: شهرکرد-بروجن-خیابان سیاسرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8815894749
Phone: +98 31 5546 3378
Fax:
Email: heidari.reza1995@gmail.com
Web page address:
Name of recruitment center - English: Amin Welfare Organization Name of recruitment center - Persian: سازمان بهزیستی امین Full name of responsible person - English: Reza Heidari-Soureshjani Full name of responsible person - Persian: رضا حیدری سورشجانی Street address - English: Shahrekord-Boroujen-siasard street Street address - Persian: شهرکرد-بروجن-خیابان سیاسرد City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8815894749 Phone: +98 31 5546 3378 Fax: Email: heidari.reza1995@gmail.com Web page address:
Protocol summary
Study aim
The aim of this study is to determine the effects of combined probiotic and selenium supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with Alzheimer's disease.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Alzheimer's disease and aged 50 to 90 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Patients will be assigned to receive selenium supplements (n=30)and combined probiotic and selenium supplementation (n=30) and placebo (n=30).
Main outcome variables
Fasting blood samples will be taken at baseline and after 12-week intervention and insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034497N5
Registration date:2018-04-02, 1397/01/13
Registration timing:retrospective
Last update:2018-12-28, 1397/10/07
Update count:2
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Omid Reza Tamtaji
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1157
Email address
tamtaji-or@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-29, 1396/10/08
Expected recruitment end date
2018-01-19, 1396/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with Alzheimer's disease
Public title
Effect of combined probiotic and selenium supplementation in treatment of patients with Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Alzheimer's disease
Individuals aged 50 to 90 years
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate.
Age
From 50 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<70 and ≥70 y), subjects will be randomly divided into three groups to take either selenium supplements + probiotic placebos (n = 30) or selenium and probiotic supplements (n = 30) or selenium and probiotic placebos (n = 30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the neurology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2017-12-28, 1396/10/07
Ethics committee reference number
IR.Kaums.REC.1396.65
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Bifidobacterium lactis (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and bifidobacterium longum (2×109 CFU/g) and selenium (200 µg), daily, for 12 weeks.