Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059042) titled 'Evaluation study on the effects of the test food on cognitive function' on April 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - Healthy participant
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous consumption of the test food on cognitive function
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of the test food for 12 weeks
Interventions/Control_2 - Ingestion of the placebo food for 12 weeks
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy male or female participants aged 40 to 69 years at the time of informed consent
2) Participants who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail
Key exclusion criteria - Participants
1) who are currently receiving medication for any illness
2) who have or are being treated for dementia or other memory impairment disorders
3) who have routinely taken medication for disease treatment within the past month (excluding as-needed use for headache, menstrual pain, cold, etc.)
4) with a past or current history of serious disorders of the liver, kidney, heart, lung, blood, etc.
5) with concurrent or past gastrointestinal diseases (except for past diseases judged by the principal investigator not to affect participation in the study)
6) with food allergies (including a history of these allergies, especially milk and soy)
7) who are pregnant, lactating, or planning to become a pregnant during the study period
8) with alcoholism or other psychiatric disorders
9) who currently smoke
10) who may change their daily lifestyle habits during the study period (e.g., moving, night shift work, long trips, etc.)
11) who may develop seasonal allergic symptoms (e.g., hay fever) during the study period
12) who have a habit of continuously consuming foods with health claims (e.g., Foods for Specified Health Uses, and Foods with Function Claims), health foods, or supplements that claim to have effects on cognitive function, currently or within the past three months, or those who plan to take them during the study period
13) who currently or within the past three months have routinely taken drugs labeled or claimed to have effects on cognitive function
14) who have received inpatient medical treatment within the past six months, or who are expected to be hospitalized during the study period
15) who participated in another clinical study within the past one month, or who plan to participate in another clinical study during the study period
16) judged by the principal investigator to be unsuitable for study participation
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 08 Month 28 Day
Date of IRB - 2025 Year 08 Month 28 Day
Anticipated trial start date - 2025 Year 11 Month 11 Day
Last follow-up date - 2026 Year 02 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067537
Disclaimer: Curated by HT Syndication.
