Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females aged 40 to 65 years at the time of informed consent 2)Persons who are aware of cognitive decline 3)Patients who can consume the test food continuously every day for 4 weeks. 4)Persons with MMSE scores of 24 or higher 5)A person who has received sufficient explanation on the purpose and content of the research, who has the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who has given written consent to participate in the research.
Exclusion criteria
Exclusion criteria: 1)A person who is currently receiving any drug treatment or ambulatory treatment. 2)A person who is currently engaged in exercise or diet therapy under the supervision of a physician. 3)Persons with a history or present disease or complication of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases 4)Persons with a history of drug or food allergy 5)Persons who wish to do so during pregnancy, lactation, or the study period 6)Persons with serious brain disease or a history 7)Persons who have received blood donations or vaccinations within the last 3 months or who may receive them during the study period. 8)Persons who routinely consume health foods, supplements, and pharmaceuticals that affect cognitive function 9)Persons with psychiatric disorder (depression, etc.) or sleep disorder, etc. who have visited the hospital or have previously visited the psychiatric department. 10)Alcohol-dependent, drug-dependent, or drug-abused persons who are being treated or have a history of such treatment 11)Persons who work on a shift basis, such as those who work at night 12)Those who eat extremely biased meals 13)Persons with extremely irregular lifestyle habits such as diet and sleep 14)Individuals who have participated in other clinical trials (studies) within 3 months from the date of informed consent, or who plan to participate in other clinical trials (studies) during the course of this study 15)Persons with difficulties in observing records on various questionnaires 16)Other persons who are judged by the investigator to be inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE,Subjective symptom questionnaire,IGF-1 | — |
Countries
Japan
Contacts
Public ContactOchitani Daisuke
HUMA R&D CORP Clinical Development Division
Outcome results
None listed