Clinical trial NCT04431843: the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: Spirulina maxima Extract
Cognitive Function
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 evaluation items when Spirulina maxima extract was taken 12 weeks compared with placebo.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Changes of Visual learning test
timeFrame: 12 weeks
measure: Changes of Visual working memory test
timeFrame: 12 weeks
measure: Changes of Verbal learning test
timeFrame: 12 weeks
Secondary outcomes:
measure: MoCA-K; Korean Version of the Montreal Cognitive Assessment
timeFrame: 12 weeks
measure: Changes of Auditory continuous performance test
timeFrame: 12 weeks
measure: BDNF; Brain-derived neurotrophic factor
timeFrame: 12 weeks
measure: Changes of TAS(Total antioxidant status)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Young-chul Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: