Healthy subjects
Conditions
Interventions
Continuous intake of test foods 1 for 12 weeks
Continuous intake of test foods 2 for 12 weeks
Continuous intake of control foods for 12 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women aged between 50and 75 years old at the time of obtaining written consent. 2. Subject who is aware of cognitive decline. 3. Subject who has a MMSE-J score of 22 points or more. 4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who has been diagnosed with dementia by a physician. 2.Subject who is taking medication or under medical treatment due to serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who is at risk of showing allergic symptoms to 28 food allergens (7 allergens (egg, milk, wheat, peanut, shrimp, buckwheat, crab) obligated and 21 allergens (kiwifruit, walnut, soybean, banana, yam, cashew nut, peach, sesame, mackerel, salmon, squid, chicken, apple, matsutake mushroom, orange, beef, gelatin, pork, abalone, salmon roe, almond) recommended for labeling) 5.Subject who has or had a history of either medicine or alcohol dependence syndrome. 6.Subject who are currently attends a hospital or has a history of mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.) 7.Subject whose working hours are irregular due to night shifts, etc. 8.Subject who has extremely irregular lifestyle habits such as eating and sleeping. 9.Subject who has an extremely unbalanced diet. 10.Smoking more than 21 cigarettes/day or heavy alcohol drinkers (average net alcohol intake of about 60 g/day or more) 11.Subject 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. 12.Subject 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. 13.Subjects who has a habit of taking products containing ingredients of test foods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BDNF,Cognitrax | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Brain Health Check (expanded version), Pittsburgh Sleep Questionnaire (Safety evaluation) Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed