]>
IRCT20170612034497N6 IRCT 2019-12-04 Kashan University of Medical Sciences Effect of spirulina supplementation in treatment of patients with Alzheimer's disease 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 2019-07-30 anticipated 60 Complete https://irct.ir/trial/43113 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Alzheimer's disease. Intervention 1: Intervention group: 500 mg spirulina oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks. Intervention 2: Control group: Placebo oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Ebrahim Kouchaki
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5562 0608 koochaki_2003@yahoo.com Kashan University of Medical Sciences scientific Ebrahim Kouchaki
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5562 0608 koochaki_2003@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with Alzheimer's disease Individuals aged 55 to 90 years 55 years 90 years Both 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 G30 Alzheimer's disease Treatment - Drugs Placebo Intervention group: 500 mg spirulina oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks. Control group: Placebo oral capsule (Khalije Fars Biotechnology Development Company), twice a day, for 12 weeks. Cognitive function. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Mini Mental State Exam (MMSE). Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Kashan University of Medical Sciences Approved 2019-07-29 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)