None listed
Conditions
Interventions
[1]Oral ingestion of a test food (1 time). [2]Observation. [3]Washout (over 3days) [4]Oral ingestion of a Control food. (1 time). [5]Observation.
[1]Oral ingestion of a Control food (1 time). [2]
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 30-49 years. [2] Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3] Individuals whose written informed consent has been obtained. [4] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals with or under treatment for memory impairment such as dementia [6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7] Individuals whose BMI is over 25kg/m2. [8] Individuals who do not have the habit of eating breakfast and those who have irregular eating habits. [9] Individuals who are sensitive to the test food. [10] Individuals who are not good ingesting caffeine-containing foods such as coffee. [11] Individuals who are a smoker. [12] Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). [13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [14] Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15] Individuals who are or are possibly pregnant, or are lactating. [16] Individuals who participated in other clinical studies in the past 3 months. [17] Individuals who are or whose family is engaged in functional foods or cosmetics. [18] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1] Cognitive function test (1) [2] Work efficiency inspection (1) [3] Questionnaire survey on sensation (1) (1): Screening,Before and after ingestion of the test food. [observation period I and II] | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Blood pressure,pulsation (Screening, Before ingestion of the test food. [observation period I and II]). [2] Subject's diary (From the first day of ingestion of a test material to the last day of the test). [3] Doctor's questions (Screening, After ingestion of the test food. [observation period I and II]). *Other indexes [1] Baseline characteristics (Screening). [2] Weight,body fat percentage,BMI (Screening). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed