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Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study)

Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study) - Single dose study of Ketonformula for standardization of cancer ketogenic diet therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032634
Enrollment
24
Registered
2018-06-30
Start date
2018-07-01
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

Healthy adult

Interventions

A single serving of the 50g placebo formula A single serving of the 50g placebo formula and the 25g Ketonformula A single serving of the 25g placebo formula and the 50g Ketonformula A single serving o

Sponsors

Graduate School of Medicine, Osaka University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Subjects who have given written informed consent 2) Healthy males aged 20 to 40 years old 3) Subjects whose blood test value and urine test value are within the normal range 4) Subjects whose BMI is 18.5 to 25

Exclusion criteria

Exclusion criteria: 1) Subjects having a smoking habit 2) Subjects receiving drug treatment 3) Subjects whose blood test value and urine test value are out of the normal range 4) Subjects with gastrointestinal complications 5) Subjects with allergies to milk, soybean, or pork 6) Subjects with lactose intolerance 7) Subjects undergoing carbohydrate restriction or ketogenic diet 8) Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.

Design outcomes

Primary

MeasureTime frame
plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)

Secondary

MeasureTime frame
Acetone concentration in breath plasma concentration of medium chain fatty acids

Countries

Japan

Contacts

Public ContactKeisuke Hagihara

Graduate School of Medicine, Osaka University Department of Advanced Hybrid Medicine

hagihara.keisuke@gmail.com06-6210-8349

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026