Clinical trial of the effect of spirulina supplementation compared with the placebo on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease
The aim of this study is to determine the effects of spirulina supplementation on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function 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
Madar and Shayestegan Welfare Organizations (Shahrekord, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Alzheimer's disease and aged 55 to 100 years will be included in this study. Exclusion criteria: Patients with metabolic syndrome, diabetes, cardiovascular disease, chronic infections, consuming spirulina supplements within 8 weeks prior to the study and taking antioxidants supplements will be excluded.
Intervention groups
Patients will be assigned to receive spirulina supplements (n=30) and placebo (n=30).
Main outcome variables
Insulin resistance, inflammatory factors and biomarkers of oxidative stress, and cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170612034497N6
Registration date:2019-12-04, 1398/09/13
Registration timing:registered_while_recruiting
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
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
2019-07-30, 1398/05/08
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of spirulina supplementation compared with the placebo on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease
Public title
Effect of spirulina supplementation in treatment of patients with Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Alzheimer's disease
Individuals aged 55 to 90 years
Exclusion criteria:
Patients with metabolic syndrome
Patients with cardiovascular disease
Patients with chronic infections
Consuming spirulina supplements within 8 weeks prior to the study
Taking antioxidants supplements
Patients with diabetes
Age
From 55 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline, participants based on balanced blocked randomization will be allocated into two groups to take either spirulina supplements (n = 30) or placebo (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 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
2019-07-29, 1398/05/07
Ethics committee reference number
IR.Kaums.MEDNT.REC.1398.050
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
Cognitive function
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Mini Mental State Exam (MMSE)
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
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
High-sensitivity C-reactive protein
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
ELISA kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
11
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Intervention groups
1
Description
Intervention group: 500 mg spirulina oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks.