Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062630) titled 'Effects of Test Food on Brain Function: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial' on Aug. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous consumption of test food on the maintenance and improvement of cognitive function in healthy young adults.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of the test food for 12 weeks
Interventions/Control_2 - Oral consumption of the placebo food for 12 weeks
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy males and females aged 18 to 29 years at the time of informed consent.
2. Individuals whose native language is Japanese.
3. Individuals who are able to visit the study site on the designated dates and undergo the required examinations and assessments.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who are unable to complete the study assessments due to conditions that interfere with testing (e.g., color vision deficiency, injuries or diseases affecting computer operation, or inability to complete the assessments even with assistive devices such as eyeglasses or hearing aids).
2. Individuals with a current or past diagnosis of dementia, psychiatric disorders (including depression and sleep disorders), neurological disorders, or cerebrovascular diseases, or those suspected of having any of these conditions.
3. Individuals with chronic diseases, such as diabetes mellitus, hypertension, or dyslipidemia, who routinely take medications.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (e.g., products claiming benefits related to cognitive function).
5. Individuals who are taking medications that could affect the study, such as antibiotics, probiotics, medications for constipation, or laxatives and who are unable to restrict their use from the time of consent acquisition.
6. Individuals who consume foods rich in lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber (excluding fresh foods), Bacillus subtilis var. natto, or butyric acid-producing bacteria at least five times per week. Individuals who consume such foods less than five times per week are eligible, provided that they do not increase their intake frequency or amount during the study period.
7. Individuals who are participating in, have completed within the past four weeks, or are planning to participate in clinical trials of pharmaceuticals or health foods.
8. Individuals with excessive alcohol intake or alcohol dependence.
9. Smoker
10. Individuals with current and/or past serious diseases of the heart, liver, kidneys, digestive organs, or other organs.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 21 Day
Date of IRB - 2026 Year 07 Month 17 Day
Anticipated trial start date - 2026 Year 08 Month 21 Day
Last follow-up date - 2027 Year 02 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071262
Disclaimer: Curated by HT Syndication.
