None listed
Conditions
Interventions
[1]Oral ingestion of a test product (1 time). [2]Observation. [3]Washout (over 6 days) [4]Oral ingestion of the control product (1 time). [5]Observation.
[1]Oral ingestion of the control product (
Sponsors
CXwellness, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese males who are aged 30-64 years and whose written informed consent has been obtained. [2]Individuals who can stop taking supplements, foods, and healthy teas that may affect the test from 3 days prior to the start of the test until the end of the test. [3]Individuals who can stop intaking medicine(s) 1 month prior to the test. [4]Individuals who can stop consuming foods and beverages containing catechins or caffeine, such as tea (green tea, black tea, oolong tea, jasmine tea, etc.), coffee, wine, etc., from 3 days prior to the test day until the end of the test. [5]Individuals who can maintain a consistent daily routine during the test period. [6]Individuals who have ingested the test product beforehand and confirmed that they can ingest it without any problems (conducted in the screening test). [7]Individuals who can communicate in Japanese or English without any problems.
Exclusion criteria
Exclusion criteria: [1]Individuals who are patient or have a history of diabetes, heart disease, kidney disease, cancer and other diseases. [2]Individuals who use medical products. [3]Individuals who have been taking healthy tea, supplements, and other products containing tea catechins continuously within 1 month of the start of the study. [4]Individuals with serious anemia. [5]Individuals who drink tea beverages over 1 L or more in a day. [6]Individuals who cannot maintain their daily routine due to significant changes in diet and physical activity. [7]Individuals who are sensitive to ingredients such as caffeine and catechins, causing eczema, nausea, and diarrhea. [8]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 20g/day). [9]Subjects who are pregnant, lactating, or intending to be pregnant. [10]Individuals whose BMI is over 30 kg/m2. [11]Individuals who participate with other clinical trial in the past 1 month. [12]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood catechin concentration (before ingestion, and 1,3,6,8,10,24 hours after ingestion. [observation period I and II]). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1] Catechin density in urine. *Other index [1]Blood pressure, pulsation. [2]Weight, body fat percentage, BMI. [3]Hematologic test. [4]Blood biochemical test. [5]Urine analysis. [6]Subject's diary. [7]Doctor's questions. [8]Questionnaire of physical feeling. | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Director
Outcome results
None listed