Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial

Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial - Preliminary test of safety of oral ingestion of foods containing large amounts of carbon dioxide

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025146

Enrollment

Registered

2017-07-01

Start date

2016-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Within 1 day, a participant ingests three different types of test foods that contain large amounts of carbon dioxide. Individual test food servings are 0.5-10 g.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Male and female subjects aged 20-64 years old and who give written informed consent (2) Give written informed consent after receiving sufficient explanation of the study purpose and details, thoroughly understand the study, and of their own free will decide to participate

Exclusion criteria

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 a disease of the respiratory system (4) Have a disease and/or previous history of disease of the heart (5) Have a serious disorder and/or chronic disorder such as hyperlipidemia, diabetes, and/or a disease of the kidneys or liver (6) Are participating in other clinical studies on medicine, cosmetics, or food (7) Are for other reasons deemed by the principal investigator as unsuitable for this study

Design outcomes

Primary

Measure	Time frame
End-tidal carbon dioxide partial pressure	—

Secondary

Measure	Time frame
Pulse oximeter oxygen saturation, Electrocardiogram, Heart rate, Blood pressure, Respiratory rate, Thoracic motion	—

Countries

Japan

Contacts

Public ContactAi Sato

Kirin Company, Limited Beverages Laboratories, Research and Development Division

Ai_sato@kirin.co.jp080-2990-3796

Outcome results