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

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Dietary Supplement: Spirulina maxima extract; Dietary Supplement: Placebo

• Registration Number: NCT04431843
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spirulina maxima extract	Spirulina maxima extract	Spirulina maxima extract for 1.5 g/day
Placebo	Placebo	Spirulina maxima extract for 0 g/day

Primary Outcome Measures

Name	Time	Method
Changes of Visual learning test	12 weeks	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.
Changes of Visual working memory test	12 weeks	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.
Changes of Verbal learning test	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
BDNF; Brain-derived neurotrophic factor	12 weeks	Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
Changes of TAS(Total antioxidant status)	12 weeks	Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized.
MoCA-K; Korean Version of the Montreal Cognitive Assessment	12 weeks	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.
Changes of Auditory continuous performance test	12 weeks	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.

Trial Locations

Locations (1)

Department of Psychiatry, Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of