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An Exploratory Study of Lactilactobacillus sakei D279 Strain (LiveOle) for Immunomodulatory Effects in Healthy Adults - a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study-

An Exploratory Study of Lactilactobacillus sakei D279 Strain (LiveOle) for Immunomodulatory Effects in Healthy Adults - a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study- - An Exploratory Study of Lactilactobacillus sakei D279 Strain (LiveOle) for Immunomodulatory Effects in Healthy Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051225
Enrollment
60
Registered
2023-09-10
Start date
2023-09-11
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 one placebo diet tablet once a day after breakfast with tap or warm water. Take one test diet, low-dose, tablet once a day after breakfast with tap or warm water. Take one test diet, high-dose, t

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged over 40 years of age and less than 60 years of age. 2. Japanese Male and female adults. 3. BMI less than 30.0kg/m^2. 4. Who is aware of their susceptibility to colds. 5. Who can use smartphones or PC to record a daily diary. 6. 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. Receive diet or exercise therapy under medical supervision. 3. Have serious illnesses or a history of serious illnesses. 4. Have immune disorders such as atopic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis. 5. Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacteria. Who can discontinue intake during the study is acceptable. 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. Be vaccinated against influenza viruses or SARS-CoV-2 within one month before the first study visit, or have the plan to be vaccinated during the study. 8. Have allergies to drugs or foods. 9. Workers on night shifts or with irregular work schedules. 10. Alcohol drinkers, over an average of 40 g/day. 11. Smoker, over 20 cigarettes/day. 12. Plans to make significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits. 13. Plans to travel abroad during the study period. 14. Currently pregnant or breastfeeding, or planning to become pregnant during the study. 15. 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. 16. Who are unsuitable for the study, as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Subjective questionnaires (cold-like symptoms) Immunological functions RNA-seq Blood cortisol Skin questionnaires Fatigue VAS Stress evaluation (PHRFSCL-SF) Sleep assessment (OSA-MA, MCTQ) SF-8 Skin elasticity, Skin moisture Biological information monitoring via wearable devices

Countries

Japan

Contacts

Public ContactHirokuni Kayama

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