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Evaluation of the prototype device for neutral fat monitoring by high-fat meal tolerance test

Evaluation of the prototype device for neutral fat monitoring by high-fat meal tolerance test - Evaluation of the prototype device for neutral fat monitoring by high-fat meal tolerance test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053480
Enrollment
10
Registered
2024-02-02
Start date
2024-02-06
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

None listed

Interventions

Oral 40g fat(venous blood collection) Oral 40g fat(device)

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Males and females aged 20 years or older at the time of informed consent. 2)Subjects who can make self-judgment and voluntarily gave written informed consent. 3)Subjects whose fasting neutral fat levels are 150mg/dL or more and less than 300mg/dL at a health checkup within the past year.

Exclusion criteria

Exclusion criteria: 1)Subjects who are on treatment for a serious illness. 2)Subjects who have been diagnosed with dyslipidemia, nephrotic syndrome, pancreatitis, hypothyroidism, or diabetes mellitus and who are on treatment or medication. 3)Subjects with food allergy. Subjects who are at risk of developing allergies related to the 40g high-fat meal tolerance test. 4)Subjects who regularly use licensed drugs or quasi-drugs that may affect the study. 5)Subjects who are currently on treatment at a medical institution for a disease that may affect the study. 6)Subjects who are participating in a clinical trial or have participated in another clinical trial within 1 month before the date of consent for this study. 7)Subjects who are pregnant and those who are breastfeeding. 8)Subjects who plan to participate in another clinical trial during this study period. 9)Subjects who have difficulty in wearing the prototype device. 10)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.

Design outcomes

Primary

MeasureTime frame
Correlation between the prototype device and the following neutral fat levels

Secondary

MeasureTime frame
1)Blood glucose level by venous blood collection. 2)Blood glucose level by continuous glucose monitoring.

Countries

Japan

Contacts

Public ContactMasako Mizuuchi

APO PLUS STATION CO., LTD CRO Business division

food-contact@apoplus.co.jp03-6386-8809

Outcome results

None listed

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