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

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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Spirulina maxima extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young-chul Chung, MD; Phone Number: 82 63 250 2185; Email: chungyc@jbnu.ac.kr

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Spirulina maxima extract; Spirulina maxima extract for 1.5 g/day	Dietary supplement: Spirulina maxima extract; 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
PLACEBO_COMPARATOR: Placebo; Spirulina maxima extract for 0 g/day	Dietary supplement: Placebo; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2020
• Primary Completion (ACTUAL): November 26, 2020
• Study Completion (ACTUAL): November 26, 2020

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive Function; Spirulina maxima Extract
• Other Study ID Numbers: KIOST-CF-SM2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No