Skip to content

Immunoregulatory effect of Ascophyllan HS

Verification of immunoregulatory effect of the supplement "Ascophyllan HS"

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230038
Enrollment
12
Registered
2023-06-16
Start date
2023-06-16
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

Able-bodied person

Interventions

Group A (Ascophyllan HS): 6 cases Ascophyllan HS: 20 mg [20%] of ascofiran per tablet One tablet once a day (between 11 am and 1 pm after lunch) for 28 consecutive days Group P (placebo): 6 cases One
Ascophyllan

Sponsors

Mizuno Shohei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 20 to 60 years of age with no subjective symptoms (symptoms caused by any disease). Drinking habit less than 3 times a week, up to 180 ml of sake (beer: 500 ml, wine: 180 ml, shochu: 110 ml, whiskey: 60 ml). Normal liver and kidney function within the last year. Body Mass Index: greater than 16 and less than 25. Written explanation and written consent have been obtained. Employees in Aichi Medical University or their referrals. Usually one bowel movement within 3 days.

Exclusion criteria

Exclusion criteria: Currently receiving drug therapy. Currently suffering from a chronic disease (cardiac, pulmonary, renal, gastrointestinal, inflammatory, etc.) Invasive cancer within the last 5 years. Non-invasive cancer within the last 1 year. Smoked within the last year. Taken health foods, supplements, or vitamins containing ascophyllan within the last 2 weeks. Pregnant or breastfeeding women. History of hypersensitivity to supplements containing ascophyllan. Student at Aichi Medical University. Inappropriate by the study investigator.

Design outcomes

Primary

MeasureTime frame
The difference in NK cell activity with oral ascophyllan HS (29th day of the study)

Secondary

MeasureTime frame
The difference in the number of T cells, B cells, and plasmacytoid dendritic cells by oral administration of ascophyllan HS (up to 43 days after the start of the study) The difference in surface antigen expression on NK cells, T cells, B cells, and plasmacytoid dendritic cells by oral administration of ascophyllan HS (up to 43 days of the study) Associated toxicity after initiation of oral administration of ascophyllan HS (up to 43 days of the study) The differences in expression of inflammatory cytokines after oral administration of ascophyllan HS (up to 43 days of the study) The differences in HDL-C, LDL-C, triglycerides, glucose, HbA1c, and glycoalbumin with oral administration of ascophyllan HS (up to 43 days of the study) Percentage of weight gain or loss due to oral administration of ascophyllan HS (up to 43 days of the study) Changes in fecal microflora due to oral administration of ascophyllan HS (up to 43 days of the study) Changes in the presence and severity of general malaise, fever, cough, sore throat, and active infection (from day 44 to day 58 of the study)

Contacts

Public ContactShohei Mizuo

Aichi Medical University Hospital

shohei@aichi-med-u.ac.jp+81-561-62-3311

Outcome results

None listed

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