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A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride. : Randomised double-blind placebo-controlled trial

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride. : Randomised double-blind placebo-controlled trial - A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial serum triglyceride.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036241
Enrollment
30
Registered
2019-03-18
Start date
2019-03-18
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

Food containing test food + high fat meal, single ingestion [Wash out for 1 week] Food not containing test food + high fat meal, single ingestion Food not containing test food + high fat meal, single

Sponsors

Allegro Inc.
Lead Sponsor
MC Food Specialties Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females, aged 20 - 65 years old. 2) Individuals whose fasting serum triglyceride level is less than 150 mg/dL 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Individuals whose fasting serum triglyceride level is greater than or equal to 150 mg/dL. 2) A medical history of malignant tumor, heart failure or myocardial infarction. 3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4) Subjects who currently on medications (including herbal medicines) 5) Subjects who are allergic to medicines and/or the test food related products. 6) Subjects with irregular life rhythms such as shift workers, irregular eating habits. 7) Subjects who are pregnant, breast-feeding, or planning to get pregnant. 8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial. 9) Subjects who are considered as ineligible to participate in the study by the physician.

Design outcomes

Primary

MeasureTime frame
serum triglyceride *Measure at before ingestion and 1, 2, 3, 4, 5, 6 hours after ingestion.

Countries

Japan

Contacts

Public ContactFumiko Kase

Allegro Inc. Clinical trial promotion department

f-kase@bml.co.jp03-5363-6821

Outcome results

None listed

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