A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study

A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study - A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061861

Enrollment

Registered

2026-06-10

Start date

2026-06-10

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

&lt

Duration&gt

Single ingestion &lt

Test product&gt

Test1: Low carb bar containing medium chain fatty acid Test2: Isocaloric low carb bar *Test 1 followed by Test 2. *The washout period is one week. &lt

Test1: Isocaloric low carb bar Test2: Low carb bar containing medium chain fatty acid *Test 1 followed by Test 2. *The washout period is one week.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose BMI is 18.0 or more and less than 25.0

Exclusion criteria

Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 5. Individuals who are taking or using medicines (including herbal medicines) or supplements 6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to wheat, milk, soybeans, almonds, walnuts, oranges, bananas, apples, or cashew nuts. 7. Individuals who are pregnant, lactating, or planning pregnancy during this study 8. Individuals who are on ketogenic diet 9. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
1. The incremental area under the curve (IAUC) of 3-hydroxybutyric acid	—

Secondary

Measure	Time frame
1. The total areas under curve (TAUC) and the maximum blood concentration (Cmax) of 3-hydroxybutyric acid, and the measured values of 3-hydroxybutyric acid at each assessment point 2. IAUC, TAUC, and Cmax of glucose, and the measured values of glucose at each assessment point 3. IAUC, TAUC, and Cmax of insulin, and the measured values of insulin at each assessment point 4. The measured values of subjective satiety at each assessment point 5. Individuals who experienced adverse events	—

Measure

Time frame

1. The total areas under curve (TAUC) and the maximum blood concentration (Cmax) of 3-hydroxybutyric acid, and the measured values of 3-hydroxybutyric acid at each assessment point 2. IAUC, TAUC, and Cmax of glucose, and the measured values of glucose at each assessment point 3. IAUC, TAUC, and Cmax of insulin, and the measured values of insulin at each assessment point 4. The measured values of subjective satiety at each assessment point 5. Individuals who experienced adverse events

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026