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A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method

A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method - A clinical study for evaluating the effects of intake of test food on cognitive function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052060
Enrollment
150
Registered
2023-08-30
Start date
2023-09-06
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 adult

Interventions

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females from 60 to 74 years old (2) Subjects who are concerned about cognitive functions such as forgetfulness (3) Subjects with an MMSE score of >=24 and <=29 (4) Subjects who understand sufficiently the purpose and content of this study and voluntarily agree to participate in this study

Exclusion criteria

Exclusion criteria: Subjects (1) with an MMSE score of <=23 (2) who have difficulty distinguishing colors and performing cognitive tests (3) with poor eyesight (4) with poor hearing (5) who have difficulty operating a computer (6) who cannot answer online survey (7) who have or have a history of dementia, mental disease, etc. or who are suspected (8) who have or have a history of drug or alcohol dependence (9) who have a menopausal disorder (10) who have or have a history of serious illness (11) who take medicines that may affect the research (12) who may develop allergies (13) who continuously take health foods that may affect cognitive function (14) who continuously take health foods that may affect blood biomarkers and cannot stop during the study (15) who continuously take foods containing a lot of lactic acid bacteria, etc. or medicines that may affect the intestinal environment (16) who are lactose intolerant or prone to diarrhea caused by dairy products (17) who are prone to diarrhea due to alcohol intake (18) who have diarrhea frequently (19) who have irregular lifestyle habits multiple times during the study (20) who plan to change their lifestyle during the study (21) who smoke more than 21 /day (22) who regularly take too much alcohol (23) who have participated in other study within a month before the consent or who plan to participate in other study during the study (24) who have taken a cognitive test conducted in this study within 3 months before the test, or who plan to take a cognitive test during the study (25) who donated or received blood transfusion within 3 months before the screening test, or donated blood components within 2 weeks before the test (26) who are judged to be unsuitable from the lifestyle questionnaire (27) who are judged to be unsuitable based on the results of clinical or physical examination (28) who are judged to be unsuitable by doctor for other reasons

Design outcomes

Primary

MeasureTime frame
Cognitive function tests

Secondary

MeasureTime frame
Blood biomarkers (antioxidant, inflammation, glucose metabolism, lipid metabolism) Subjective psychological assessments

Countries

Japan

Contacts

Public ContactMariko Kondo

EP Mediate Co., Ltd. Foods Department, Trial Planning Section 2

kondo.mariko793@eps.co.jp070-3023-8211

Outcome results

None listed

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