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Effect of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study-

Effect of intake of a test food on postprandial blood triglyceride level -a randomized, double blind placebo-controlled, cross-over study- - Effects of a test food on postprandial blood triglyceride level

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044700
Enrollment
100
Registered
2021-06-30
Start date
2021-06-30
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 (who has fasting blood triglyceride level less than 150 mg/dl )

Interventions

Single ingestion of the placebo food-washout period (6 days or more)-single ingestion of the test food Single ingestion of the test food-washout period (6 days or more)-single ingestion of placebo foo

Sponsors

Pharma Foods International Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy subjects aged 20 to 65 years old. (2) Subjects whose fasting serum triglyceride levels are less than 150 mg/dL. (3) Subjects giving written informed consent.

Exclusion criteria

Exclusion criteria: a. Subjects who have a history of treatment for malignancy, heart failure and myocardial infarction b. Subjects who are being treated for the following chronic diseases; atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases c c. Frequent users of medicine (includes TCM) and/or supplements and/or health foods that could affect lipid metabolism. d. Subjects who have allergy (medical products, test food related food) e. Subjects who are pregnant or breastfeeding or planning to get pregnant during the study f. Subjects who are judged as unsuitable for the study by the physician in change due to other reason.

Design outcomes

Primary

MeasureTime frame
The difference of serum triglyceride level at sequential sampling time points and AUC (area under the blood concentration - time curve) (before ingestion of high fat diet, and 2, 3, 4, 6 hours after ingestion of a high fat)

Secondary

MeasureTime frame
The difference of serum RLP cholesterol level at sequential sampling time points and AUC Other lipid metabolism related factors (Total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, beta lipoprotein, lipoprotein fraction, phospholipid) (before ingestion of high fat diet and 2, 3, 4, 6 hours after ingestion of a high fat) Height, body weight, BMI(before ingestion of high fat diet)

Countries

Japan

Contacts

Public ContactHiroaki Yamada

Pharma Foods International Co., Ltd. R&D department

h-yamada@pharmafoods.co.jp075-748-9829

Outcome results

None listed

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