Healthy subjects
Conditions
Interventions
Continuous intake of food containing plant extract for 16 weeks.
Continuous intake of placebo for 16 weeks.
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females aged 40 to under 60 years at the time of written informed consent. 2.Subjects who feel they are experiencing cognitive decline (with a total SCD-Q (My-Cog) score of 7 or higher) 3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of gastrointestinal resection surgery (excluding appendectomy). 2.Subjects with an MMSE score of 27 or lower. 3.Subjects who have been diagnosed with dementia or mild cognitive impairment (MCI). 4.Subjects with a serious illness under treatment or a history of serious disease requiring medication. 5.Subjects with a history of diagnosis or treatment for psychiatric disorders (e.g., depression), or who are considered to have unstable psychiatric symptoms during the study period. 6.Subjects who have been continuously consuming drugs, Foods for Specified Health Uses, Foods with Function Claims, or health foods that may affect study outcomes at least 3 days per week over the past 3 months, and who are unable to discontinue such intake from one month before the baseline examination. 7.Subjects who have a history of or currently receive treatment for cerebrovascular disease (e.g., cerebral/subarachnoid hemorrhage, cerebral infarction/ transient ischemic attacks, cerebral aneurysm, and moyamoya disease), or who had a traumatic injury to the head within the past 10 years. 8.Subjects who have color vision deficiency or hearing impairment that may affect the cognitive function tests or other study assessments. 9.Subjects who have undergone cognitive function tests (e.g., neuropsychological assessments of memory and attention) within the past 12 months. 10.Subjects who have specialized knowledge of the memory and cognitive function tests used in this study. 11.Subjects who are at risk of developing allergic reactions to any study-related procedures or materials. 12.Subjects who intend to become pregnant during the study period, are pregnant (or may be pregnant), or are breastfeeding. 13.Subjects with extremely irregular lifestyles due to night shift work or rotating shift work. 14.Subjects whose lifestyle habits, including eating and sleeping patterns, are extremely irregular.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score for SCD-Q (My-Cog) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Subscale scores of the SCD-Q (My-Cog), total and subscale scores of the SCD-Q (Their-Cog), WMS-R, New Stroop Test II, and EMC, Subgroup analysis. (Exploratory outcome measures) Japanese version of the HHIA, CES-D, and biomarker measurement using stored specimens. (Safety evaluation) Vital signs, physical measurements(body weight and BMI), biochemical test, hematology test, urinalysis, adverse events. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed