Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063264) titled 'A study to investigate the effects of food containing Bifidobacterium LKM512 and arginine on cognitive function: A randomized, double-blind, placebo-controlled trial' on Oct. 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Research Laboratories, Kyodo Milk Industry Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of consuming food containing Bifidobacterium animalis subsp. lactis LKM512 and arginine on cognitive function in healthy middle-aged and older adults.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will intake 3 g of a powdered food containing at least 1 x 10^9 CFU of Bifidobacterium animalis subsp. lactis LKM512 and 600 mg of arginine once daily for 16 weeks.
Interventions/Control_2 - Participants will intake 3 g of a powdered food (placebo) containing only excipients, without Bifidobacterium animalis subsp. lactis LKM512 or arginine, once daily for 16 weeks
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Japanese men and women aged 40 years or older but younger than 79 years.
2. Healthy individuals who can perform activities of daily living without difficulty.
3. Individuals who subjectively perceive a decline in their memory.
4. Individuals who have received a sufficient explanation of the purpose and procedures of the study, fully understood the information provided, voluntarily agreed to participate, and provided written informed consent.
Key exclusion criteria - 1. Individuals with suspected dementia (defined as a MMSE score of 23 or lower).
2. Individuals with current or previous psychiatric disorders or sleep disorders.
3. Individuals with current or previous neurological or cerebrovascular diseases.
4. Individuals with current or previous serious underlying diseases, including diabetes mellitus, liver disease, kidney disease, or heart disease.
5. Individuals who regularly consume supplements, functional foods, or medications that may affect cognitive function, or who have consumed them within 3 months before providing informed consent.
6. Individuals undergoing treatment for brain function-related conditions or receiving prescribed medications related to brain function, including traditional Japanese Kampo medicines.
7. Individuals with current or previous drug or food allergies.
8. Individuals with diseases requiring continuous medication.
9. Individuals who regularly consume yogurt, lactic acid bacteria beverages, supplements, or other products containing probiotics or prebiotics, or who have consumed such products within 3 months before providing informed consent.
10. Individuals who have donated apheresis blood before the start of the study.
11. Individuals who have donated 400 mL of whole blood within 4 months before the start of the study.
12. Individuals who participated in or are currently participating in another clinical trial or clinical study within 1 month before providing informed consent.
13. Individuals who are currently pregnant or breastfeeding, or who intend to become pregnant during the study period.
14. Individuals who habitually consume excessive amounts of alcohol (equivalent to 60 g or more of pure alcohol/day).
15. Individuals with extremely irregular eating habits or irregular daily routines, including shift workers.
16. Individuals who smoke.
17. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 14 Day
Date of IRB - 2026 Year 08 Month 21 Day
Anticipated trial start date - 2026 Year 10 Month 14 Day
Last follow-up date - 2027 Year 03 Month 27 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072323
Disclaimer: Curated by HT Syndication.
