Evaluation of the efficacy of continuous consumption of the study food on immune function - A randomized, placebo-controlled, double-blind, parallel-group study -

Evaluation of the efficacy of continuous consumption of the study food on immune function - A randomized, placebo-controlled, double-blind, parallel-group study - - Evaluation of the efficacy of continuous consumption of the study food on immune function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059504

Enrollment

200

Registered

2025-11-04

Start date

2025-11-05

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

Consume one 65 mL bottle of the test beverage once each morning Consume one 65 mL bottle of the placebo beverage once each morning

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 20 to under 60 years 2. Japanese men and women 3. Have contact with others at least once a week through work or social activities 4. History of upper respiratory tract infection at least once a year 5. BMI 18.5 or more, and less than 30.0 kg/m^2 6. Able to enter electronic diaries via smartphone or PC 7. Received thorough explanation of study purpose and details, fully understood, voluntarily agreed to participate, and provided written consent

Exclusion criteria

Exclusion criteria: 1. Currently receiving outpatient treatment or medication (including herbal medicine) for any illness (as-needed use permitted) 2. Under physician-supervised dietary or exercise therapy 3. Current or past history of serious disease 4. Atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders 5. Consuming yogurt or foods containing lactic acid bacteria or bifidobacteria (eligible if discontinued after consent) 6. Currently taking quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (eligible if discontinued after consent) 7. Lactose intolerance 8. Received vaccination for influenza, COVID-19, etc., within one month before screening visit, or plans to be vaccinated during study period 9. Current or past history of drug or food allergies 10. Irregular lifestyle due to night shifts or other shift work 11. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during study period 12. Excessive alcohol consumption (>=40 g pure alcohol per day)

Design outcomes

Primary

Measure	Time frame
Questionnaire regarding physical condition	—

Secondary

Measure	Time frame
Immune cell analysis using mass cytometry, comprehensive relative quantification of blood cytokines, blood levels of cytokines	—

Countries

Japan

Contacts

Public ContactHiroyuki 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