After 16 hours of fasting Verification of the effect of ketones

After 16 hours of fasting Verification of the effect of ketones - After 16 hours of fasting Verification of the effect of ketones

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047640

Enrollment

Registered

2022-05-02

Start date

2022-05-06

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

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Japanese males between the ages of 20 and 60 years old at the time consent is obtained. 2) Persons with no abnormalities in blood glucose levels (no abnormalities in blood glucose levels ever indicated in a physical examination) 3) BMI between 18.5 kg/m2 and 22.0 kg/m2 4)Persons who are able to come to the hospital fasting, having eaten dinner by 19:00 the previous day in order to obtain values after 16 hours of fasting. 5) The patient must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.

Exclusion criteria

Exclusion criteria: 1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease 2) Currently undergoing treatment for a serious disease 3) The patient is regularly using medicines or quasi-drugs that may affect the test items. 4) Those who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items. 5) Those with extremely irregular lifestyles (e.g., working at night or living day and night in reverse) 6) Those who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent 7) Those who plan to participate in other clinical trials during the study period 8) Any other person who is judged by the investigator to be unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
total ketone body	—

Secondary

Measure	Time frame
beta-Hydroxybutyric acid (3-hydroxybutyric acid) Acetoacetic acid	—

Countries

Japan

Contacts

Public ContactMasako Mizuuchi

APO PLUS STATION CO., LTD. Clinical Operation Department, CRO Business Division

food-contact@apoplus.co.jp03-6386-8809

Outcome results