Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, single-arm, open-label trial
Not Applicable
- Conditions
- o
- Registration Number
- JPRN-UMIN000029483
- Lead Sponsor
- Kirin Company, Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(1) End-tidal carbon dioxide partial pressure is >46 mmHg at the time of the screening test (2) Are deemed unsuitable based on screening tests concerning the circulatory system (3) Have asthma (4) Have a disease of the respiratory system affecting exams (5) Have a disease and/or previous history of heart disease (6) Have a serious disorder and/or chronic disorder such as hyperlipidemia, diabetes, and/or a disease of the kidneys or liver (7) Are pregnant, or are planning to become pregnant (8) Are participating in other clinical studies on medicine, cosmetics, or food (9) Are for other reasons deemed by the principal investigator as unsuitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method End-tidal carbon dioxide partial pressure
- Secondary Outcome Measures
Name Time Method Pulse oximeter oxygen saturation, Electrocardiogram, Heart rate, Blood pressure, Respiratory rate, Thoracic motion