Safety evaluation of long-term intake of drink containing plant-derived anthocyanin for healthy adults or subjects with high normal liver functio
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000028275
- Lead Sponsor
- TTC CO., LTD.
- Brief Summary
Items in which significant changes were observed in the average values of clinical laboratory test values and measured values compared with those before ingestion were found, but both were minor fluctuations, and if they were not clinically problematic fluctuations, the doctor It was judged by the responsible person. Twenty-four adverse events occurred in eleven out of twenty-one patients, but there were no serious adverse events and symptoms were all mild, and all relevance to the research food was "None" It was done. Based on the above results, it was shown that there is no problem in safety on long-term ingestion of plant-derived anthocyanin-containing beverages under this research condition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who constantly use supplements or drugs affecting the liver function (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects having possibilities for emerging allergy related to the study (5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 4, 8, 12 weeks after intake and 4 weeks after the end of intake period and Adverse events thorough the study
- Secondary Outcome Measures
Name Time Method