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

UMIN ID: UMIN000032634

Registered date:30/06/2018

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2018/07/01
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 of the 75g Ketonformula

Outcome(s)

• Primary Outcome: plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)
• Secondary Outcome: Acetone concentration in breath plasma concentration of medium chain fatty acids

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude 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.

Related Information

• Primary Sponsor: Graduate School of Medicine, Osaka University
• Source(s) of Monetary Support: Meiji, Co., Ltd., Meiji Seika Pharma, Co., Ltd., The Nisshin OilliO Group, Ltd.