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Open-label study to confirm suppression of postprandial triglycerides elevation by seaweed extract supplementation

Single-arm open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract on the suppression of postprandial triglyceride elevation - Single-arm open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract on the suppression of postprandial triglyceride elevation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057051
Enrollment
16
Registered
2025-02-17
Start date
2025-02-22
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 (Healthy adults)

Interventions

Test food: Acid resistant hard capsule containing 40 mg seaweed (Ascophyllum nodosum) extract Intake: 1 capsule Intake period: 1 time (after blood collection before high fat diet intake) Load food:

Sponsors

Riken Vitamin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese males and females over 20 years of age at the time of consent. 2. Participants with fasting triglycerides between 30 mg/dL and 150 mg/dL within the last 6 months. 3. Participants who have been fully informed of the purpose and content of this study and who have signed an informed consent form prior to the start of this study.

Exclusion criteria

Exclusion criteria: 1. Those who are currently being treated for a serious illness. 2. Those receiving treatment, medication, or lifestyle intervention from a doctor due to dyslipidemia or diabetes. 3. Those suffering from a medical condition that may affect the test items and who are currently undergoing treatment at a medical facility. 4. Participants with food allergies or who may have an allergic reaction to the test food and high fat diet. 5. Those who regularly consume medicines or quasi-drugs that may affect the test items. 6. Those who regularly consume health foods (foods for specified health uses, food with nutrient function claims, foods with functional claims, dietary supplements, etc.) that may affect the test items. 7. Those who participate in other studies or who have participated in other studies within the past one month. 8. Pregnant, lactating, or wishing to become pregnant. 9. Those who intends to participate in other clinical studies during this study period. 10.Those who are unable to maintain their daily lifestyle (diet, exercise, smoking etc.). 11.Those determined by the principal investigator to be inappropriate in this study.

Design outcomes

Primary

MeasureTime frame
AUC of postprandial triglyceride: before and 1, 2, 3, 4, 5, and 6 hours after high fat diet

Secondary

MeasureTime frame
Efficacy postprandial triglyceride: before and 1, 2, 3, 4, 5, and 6 hours after high fat diet Cmax of postprandial triglyceride, Tmax of postprandial triglyceride Safety Incidence of side effects and adverse events: after intake

Countries

Japan

Contacts

Public ContactRyuto Takahashi

Riken Vitamin Co., Ltd. Healthcare Unit

ryu_takahashi@rike-vita.co.jp03-5362-1334

Outcome results

None listed

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