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A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial

A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial - A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052736
Enrollment
100
Registered
2023-11-12
Start date
2023-11-13
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

Take six tablets of the placebo supplement with water or warm water after breakfast every day. Take six tablets of the active supplement with water or warm water after breakfast every day.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over 20 years old and less than 65 years old. 2. Male and female. 3. BMI is over 18.5 kg/m^2 and less than 30 kg/m^2. 4. Those who have been upper respiratory infection diseases or common-cold-like symptoms over one time every year. 5. Those who work outside the home for at least 3 days of the week. 6. Those who can use smartphones or PC to record a digital diary. 7. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.

Exclusion criteria

Exclusion criteria: 1.Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable. 2.Currently receiving any dietary treatment or exercise treatment under medical doctors. 3.Have malignancy or serious illnesses, or a history of serious illnesses in respiratory, digestive, endocrine, or metabolic organs. 4.Have been received resection of digestive organs, excluding cecum resection. 5.Have been used medical drugs which have immune modulatory effects, such as anti-allergy drugs and antibiotics, within one month before the screening visit. 6.Have been taking foods or dietary supplements with functional health claims that affect the outcome of the study. Who can discontinue intake during the study is acceptable. 7.Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacterial, over three times per week. Who can discontinue intake during the study is acceptable. 8.Have allergic rhinitis. 9.Have a history or current condition of asthma or atopic dermatitis. 10.Have allergies to drugs or foods. 11.Workers on night shifts or with irregular work schedules. 12.Have been vaccinated against influenza viruses or SARS-CoV-2 or infected with these viruses within 12 weeks before the screening visit, or are planning to be vaccinated during the study. 13.Heavy Smoker, over 21 cigarettes/day. 14.Alcohol drinkers, over 40 g/day of pure alcohol. 15.Are planning to make significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits. 16.Are planning to travel abroad during the study period. 17.Currently pregnant or breastfeeding, or planning to become pregnant during the study. 18.Those who have participated in other clinical trials within one month before enrolling in the study, those who are currently participating in other clinical trials, and those who plan to participate in other clinical trials after enrolling in the study. 19.Who are unsuitable for the study, as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Subjective questionnaire

Secondary

MeasureTime frame
Protein expression of cell surface antigens on plasmacytoid dendritic cells (HLA-DR, CD40, CD80, CD86 on CD123+/BDCA4+ cells) NK cell cytotoxicity IFN-alpha and IL-12 level in blood

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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