Healthy subjects
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.Subjects who have received sufficient explanation of the purpose and content of the research, and have the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who have been diagnosed with dementia by a doctor. 2.Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. (excluding appendicitis) 3.Subjects who have food allergy. 4.Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 5.Subjects who have irregular lifestyles due to night shifts or shift work. 6.Subjects with extremely irregular lifestyle habits in terms of eating and sleeping. 7.Subjects who consistently drink more than the recommended amount of alcohol (average net alcohol intake of over 40 g/day). 8.Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, endocrine disorder, or other metabolic disorders. 9.Subjects who have a habit of consuming Camembert cheese (2 pieces a day, 5 days a week or more). 10.Subjects who are participating in other clinical studies now, or are willing to participate within 3 months prior to the date of obtaining consent. 11.Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent. 12.Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 13.Subjects who are judged to be inappropriate as research subjects according to data in screening tests. 14.Subjects who are judged unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Safety evaluation) Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events, The Japanese version of the Pittsburgh Sleep Quality Index | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed