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
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:2018-04-02, 1397/01/13
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.