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A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -

A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study - - A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056722
Enrollment
60
Registered
2025-01-20
Start date
2025-02-27
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 adults

Interventions

Participants will take three capsules of the test supplement daily after breakfast. Participants will take three capsules of the placebo supplement daily after breakfast.

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men and women aged 20 to 69 years (at the time of consent) 2. BMI less than 30.0 kg/m^2 3. Individuals who perceive themselves as prone to catching colds 4. Individuals who have had a cold in the past 2 years and engage in face-to-face work outside at least 3 days a week 5. Individuals living with family (those living alone are not eligible) 6. Individuals capable of entering electronic diaries via smartphone or PC 7. Individuals who have received sufficient explanation of the study's purpose and content, fully understand it, voluntarily wish to participate, and have given written consent

Exclusion criteria

Exclusion criteria: 1. Individuals with a current or past history of food allergies, asthma, or atopic dermatitis 2. Individuals with seasonal or perennial allergies during the trial period 3. Individuals regularly taking medications or supplements that may affect study outcomes (participation allowed if these medications or supplements can be discontinued after consent) 4. Individuals with a history of major gastrointestinal surgeries such as gastrectomy, gastrointestinal anastomosis, or intestinal resection (appendectomy is allowed) 5. Individuals with severe liver, kidney, heart diseases, organ disorders, diabetes, or other severe conditions 6. Individuals undergoing drug treatment or planning to receive treatment during the trial period (occasional use of painkillers or antihistamines is allowed) 7. Individuals unable to maintain a regular lifestyle during the trial period 8. Non-daytime workers (night shift or rotating shift workers) 9. Individuals who have donated more than 200 mL of blood within 4 weeks or more than 400 mL within 3 months before the trial 10. Smokers (including electronic cigarettes) 11. Pregnant women or those wishing to become pregnant 12. Heavy alcohol drinkers (pure alcohol intake: 40g/day or more) 13. Individuals planning to travel abroad during the trial period 14. Individuals who participated in other clinical trials within the last 3 months 15. Individuals wishing to receive influenza/COVID-19 vaccination during the trial period or within 4 weeks prior to the SCR visit date 16. Individuals considered unsuitable for study participation by the principal investigator

Design outcomes

Primary

MeasureTime frame
Expression of cell surface markers (HLA-DR, CD86, CD40, CD80) on peripheral blood pDCs

Secondary

MeasureTime frame
IFN-alpha production by PBMC Expression of cell surface markers (HLA-DR, CD86, CD40, CD80) on peripheral blood cDC1 and cDC2 Self-reported physical health outcomes

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp0367045968

Outcome results

None listed

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