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Completed

NCT Number: NCT04431843

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

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Key information

Conditions

Cognitive Function

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina maxima extract

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Changes of Visual learning test

    Time frame: 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.

  2. Changes of Visual working memory test

    Time frame: 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.

  3. Changes of Verbal learning test

    Time frame: 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 outcomes

  1. MoCA-K; Korean Version of the Montreal Cognitive Assessment

    Time frame: 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.

  2. Changes of Auditory continuous performance test

    Time frame: 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.

  3. BDNF; Brain-derived neurotrophic factor

    Time frame: 12 weeks

    Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.

  4. Changes of TAS(Total antioxidant status)

    Time frame: 12 weeks

    Total antioxidant status(TAS) was measured in baseline and 12 week. And changes of result from the test were utilized.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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