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

Chonbuk National University

Status: Completed

Conditions: Cognitive Function

Treatments: Dietary Supplement: Spirulina maxima extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04431843

KIOST-CF-SM2

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Spirulina maxima extract

Experimental group

Description:

Spirulina maxima extract for 1.5 g/day

Treatment:

Dietary Supplement: Spirulina maxima extract

Placebo

Placebo Comparator group

Description:

Spirulina maxima extract for 0 g/day

Treatment:

Dietary Supplement: Placebo