Tokyo, May 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061545) titled 'The effect of the test food (low dose) intake on cognitive functioning' on May 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - HUMA R&D CORP
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of the test food (low dose) intake on cognitive function.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Continuous intake of food containing rice protein hydrolysate for 12 weeks
Interventions/Control_2 - Continuous intake of placebo foods for 12 weeks
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Helthy Japanese males and females who are between 50 and 69 years of age at the time of written informed consent.
2.Subjects who are aware of cognitive decline.
3.Subjects whose scoring of MMSE-J is 24 or more at screening.
4.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria - 1.Subjects who have been diagnosed with dementia by a physician.
2.Subjects receiving medication or outpatient treatment for a serious disease.
3.Subjects receiving exercise or diet therapy under the supervision of a physician.
4.Subjects who may develop an allergy to the ingredient of the test food.
5.Subjects with current or previous history of drug dependence or alcohol dependence.
6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
7.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
8.Subjects whose eating, sleeping, and other habits are extremely irregular.
9.Subjects who are having a very unbalanced diet.
10.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more)
11.Subjects with smoking habits.
12.Subjects who regularly consume large amounts of caffeinated beverages (400 mg of caffeine or more per day)
13.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
14.Subjects who use or are unable to stop using health foods, supplements (e.g., ginkgo biloba extract, DHA, EPA, and GABA), and drugs that may affect cognitive functioning.
15.Subjects who regularly consume sardines, mackerels, skippers, or other similar fishes as well as foods containing these fishes.
16.Subjects with color blindness.
17.Subjects who usually use devices, equipment, and applications that may affect cognitive functions. (e.g., brain training puzzles, brain training games)
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 10 Day
Date of IRB - 2026 Year 04 Month 16 Day
Anticipated trial start date - 2026 Year 06 Month 22 Day
Last follow-up date - 2026 Year 11 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070421
Disclaimer: Curated by HT Syndication.
