the Efficacy and Safety of Spirulina Maxima Extract on Improvement of Cognitive Function

Study Overview
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Brief Summary
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This study was the evaluate the efficacy and safety of Spirulina maxima extract on the improvement of Cognitive Function

Detailed Description
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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.

Official Title
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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

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Spirulina maxima extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spirulina maxima extract<br>Spirulina maxima extract for 1.5 g/day | Dietary Supplement: Spirulina maxima extract<br>* once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week<br>|
| Placebo Comparator: Placebo<br>Spirulina maxima extract for 0 g/day | Dietary Supplement: Placebo<br>* once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Visual learning test | Visual learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized. | 12 weeks | 
| Changes of Visual working memory test | Visual working memory test of WMT(working memory tasks) was measured in baseline and 12 week. And changes of result from the test were utilized. | 12 weeks | 
| Changes of Verbal learning test | Verbal learning test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA-K; Korean Version of the Montreal Cognitive Assessment | The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point. It takes about 10 minutes to complete, and the score is 30 points. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point. | 12 weeks | 
| Changes of Auditory continuous performance test | Auditory continuous performance test of CNT(Computerized neurocognitive function test) was measured in baseline and 12 week. And changes of result from the test were utilized. | 12 weeks | 
| BDNF; Brain-derived neurotrophic factor | Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week. | 12 weeks | 
| Changes of TAS(Total antioxidant status) | Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirulina maxima Extract, Cognitive Function