Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060804) titled 'Open-label study to evaluate the effect of seaweed (Ascophyllum nodosum) extract supplementation on the suppression of postprandial triglycerides elevation' on March 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Riken Vitamin Co., Ltd.

Condition: Condition - None (Healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effect of seaweed extract intake on postprandial triglycerides elevation in healthy Japanese men and women Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 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) Load food: high fat diet (butter roll, lard and corn soup)

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 16

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 18 Day Date of IRB - 2026 Year 02 Month 25 Day Anticipated trial start date - 2026 Year 03 Month 06 Day Last follow-up date - 2026 Year 04 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069567

Disclaimer: Curated by HT Syndication.