Healthy adults
Conditions
Interventions
Ingestion of test food including milk-derived peptide (24 weeks, 4 tablets / once a day)
Ingestion of placebo food not including milk-derived peptide (24 weeks, 4 tablets / once a day)
Sponsors
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
University of Shizuoka, School of Pharmaceutical Sciences, Drug Information Analysis Seirei Social Welfare Community Toho University Sakura Hospital Koga Community Hospital Hagiwara Hospital Takido Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subjects who agreed in the written sheet to participate this intervention study. 2) The subjects who are aware of forgetfulness. 3) The subjects who can intake test foods during the test period. 4) The subjects who are able to check the diary of food intake during the intake period. 5) The subjects who displayed from 24 to 27 scores of MMSE.
Exclusion criteria
Exclusion criteria: 1) The subjects who are likely to have allergy symptoms due to test ingredients (milk). 2) The subjects who were diagnosed as patients with dementia 3) The subjects who received surgical operation for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion injury Head trauma Those with the inpatient surgery. 4) The subjects with medical history of epilepsy or diabetes and/or receiving medical treatment presently. 5) The subjects who is taking medicines (antipsychotic drugs, anxiolytics, antidepressants, antiparkinsonian drugs, antidepressants, antiepileptic drugs etc.) that have a possibility affecting on the cognitive function. 6) The subjects who are participating or planning to participate in other clinical trials at the start of this study. 7) The subjects who are judged as being inappropriate by the responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes is Rey-Osterrieth Complex Figure Test (ROCF) at pre and post (for 24 weeks) administration of the repeated intake of milk-derived peptide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is the tests below. MMSE Symbol Digit Modalities Test Verbal Fluency Test SF-8 Questionnaire physical examination hematology test urinalysis test | — |
Countries
Japan
Contacts
Public ContactYamada Shizuo
University of Shizuoka Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Outcome results
None listed