Status:
COMPLETED
the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Cognitive Function
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function
Detailed Description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects participated in Spirulina maxima extract or placebo group. To evaluate the changes in the eva...
Eligibility Criteria
Inclusion
- Persons who are at least 60 years of age at screening
- Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Exclusion
- Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Patients with BMI(Body Mass Index)\<18.5 kg/m\^ or 35 kg/m\^≤BMI(Body Mass Index)
- Patients with alcohol abuse or dependence within the last 3 months
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Patients with a history of clinically significant hypersensitivity to Spirulina Maxima
- Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
- Patients who ingested Spirulina Maxima extract's health functional food within 1 month before screening
- Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- Patients who participate in another human trial within 3 months
- Those who show the following results in the Laboratory test
- AST, ALT \> 3 times upper limit of the normal range
- Other significant laboratory test opinion
- Patients who are deemed unsuitable for participating in the human trial due to other reasons
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04431843
Start Date
March 17 2020
End Date
November 26 2020
Last Update
February 10 2023
Active Locations (1)
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1
Department of Psychiatry, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907