Healthy participants
Conditions
Interventions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women aged between 50 and 75 years old at the time of obtaining written consent. 2.Participant who is aware of their cognitive decline. 3.Participant who has a MMSE-J score of 24 points or more. 4.Participant who has received sufficient explanation of the purpose and content of the research, and has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Participant who has been diagnosed with dementia by a physician. 2.Participant who is taking medication or under medical treatment due to serious illness. 3.Participant who is under exercise therapy or dietetic therapy. 4.Participant who is at risk of showing allergic symptoms to 28 food allergens (7 allergens (egg, milk, wheat, peanut, shrimp, buckwheat, crab) required and 21 allergens (kiwifruit, walnut, soybean, banana, yam, cashew nut, peach, sesame, mackerel, salmon, squid, chicken, apple, macadamia nut, orange, beef, gelatin, pork, abalone, salmon roe, almond) recommended for labeling). 5.Participant who has or had a history of either drug or alcohol dependence syndrome. 6.Participant who currently attends a hospital for or has a history of mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.). 7.Participant whose working hours are irregular due to night shifts, etc. 8.Participant who has extremely irregular lifestyle habits such as eating and sleeping. 9.Participant who has an extremely unbalanced diet. 10.Participant who smokes more than 21 cigarettes/day. 11.Participant who drinks alcohol heavily (average net alcohol intake of about 60 g/day or more). 12.Participant with a serious current or previous illness such as brain disease, malignant tumor, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease. 13.Participant who takes supplements, health foods, etc. (including food for specified health uses and food with functional claims) or medicines that affect cognitive functions for 4 days or more per week. 14. Participant who has a habit of taking products containing the functional substance of the test food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Japanese version of the MCI Screen | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) The Japanese version of the Pittsburgh Sleep Quality Index, POMS 2-A, BDNF (Safety evaluation) Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed