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

NCT ID: NCT04431843

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-17
• Study Completion Date: 2020-11-26

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.

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Spirulina maxima extract

Spirulina maxima extract for 1.5 g/day

Group Type: EXPERIMENTAL

Spirulina maxima extract

Intervention Type: 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

Spirulina maxima extract for 0 g/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Chul Chung

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-chul Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

KIOST-CF-SM2

Identifier Type: -

Identifier Source: org_study_id