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Open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract supplementation on the suppression of postprandial triglycerides elevation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060804
Enrollment
16
Registered
2026-03-02
Start date
2026-03-06
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 (Healthy adults)

Interventions

Test food: hard capsules containing a seaweed extract formulation (equivalent to 40 mg of seaweed extract) Intake: 1 capsule Intake period: 1 time (after blood collection before high fat diet intake

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 199 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 receiving treatment 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 or 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 are participating in other studies or who have participated in other studies within the past one month 8. Pregnant or lactating individuals, or those wishing to become pregnant 9. Those who are unable to purchase the prescribed meals 10. Those who intend to participate in other clinical studies during this study period 11. Those who are unable to maintain their daily lifestyle (diet, exercise, smoking, etc.) 12. Those determined by the principal investigator to be inappropriate for 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 of the test food

Countries

Japan

Contacts

Public ContactRyo Ebihara

Riken Vitamin Co., Ltd. Health Care Unit

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

Outcome results

None listed

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