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

NCT04431843 | Completed

• 1 other identifier: KIOST-CF-SM2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Function

Keywords

Spirulina maxima Extract; Cognitive Function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• MoCA-K; Korean Version of the Montreal Cognitive Assessment

  12 weeks

• Changes of Auditory continuous performance test

  12 weeks

• BDNF; Brain-derived neurotrophic factor

  12 weeks

• Changes of TAS(Total antioxidant status)

  12 weeks

Study Arms (2)

Spirulina maxima extract

EXPERIMENTAL

Spirulina maxima extract for 1.5 g/day

Dietary Supplement: Spirulina maxima extract

Placebo

PLACEBO COMPARATOR

Spirulina maxima extract for 0 g/day

Dietary Supplement: Placebo

Interventions

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

Spirulina maxima extract

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: March 17, 2020
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

KR (1)