Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (repeated dose study)
Phase 1
Completed
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000034216
- Lead Sponsor
- Department of Advanced Hybrid Medicine Graduate School of Medicine, Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects having a smoking habit 2) Subjects receiving drug treatment 3) Subjects whose blood test value are not within the standard values 4) Subjects with gastrointestinal complications 5) Food allergies 6) Lactose intolerance 7) Subjects undergoing carbohydrate restriction or ketogenic diet 8) Subjects who were collected over 400 mL blood within 3 months 9) Subjects who participated another clinical trials within 3 months 10) Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)
- Secondary Outcome Measures
Name Time Method plasma concentration of acetoacetic acid plasma concentration of 3-hydroxybutyrate plasma concentration of medium chain fatty acids Acetone concentration in human breath