Effects of consumption of the test food on the cognitive function in healthy Japanese subjects

Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the cognitive function in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047851

Enrollment

Registered

2023-05-25

Start date

2022-05-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Capsule containing seaweed extract (derived from Monostroma nitidum) Administration: Take one capsule of the test food per day * Daily dose should be taken within th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more and less than 65 4. Healthy subjects 5. Subjects whose score of Mini Mental State Examination (MMSE) is 24 or more 6. Subjects whose score of NCI is 70 or more and less than 100

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
Neurocognition index (NCI)	—

Secondary

Measure	Time frame
The standardized scores of each cognitive function item (composite memory, verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed), vessel measurement (blood flow velocity, visibility of vessels, density of vessels, diameter of vessels, distance between vessels, length of vessels, and shape of vessels), and intestinal flora (Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII)	—

Measure

Time frame

The standardized scores of each cognitive function item (composite memory, verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed), vessel measurement (blood flow velocity, visibility of vessels, density of vessels, diameter of vessels, distance between vessels, length of vessels, and shape of vessels), and intestinal flora (Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII)

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026