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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034216
Enrollment
16
Registered
2018-11-01
Start date
2018-11-02
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

Low carbohydrate diet and the 50g placebo formula,3 times per day Low carbohydrate diet and the 50g Ketonformula,3 times per day Normal diet, 3 times per day

Sponsors

Department of Advanced Hybrid Medicine 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 BMI is 18.5 to 25.0 4) Subjects whose height is 165 cm to 175 cm

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
plasma concentration of acetoacetic acid plasma concentration of 3-hydroxybutyrate plasma concentration of medium chain fatty acids Acetone concentration in human breath

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