UMIN-CTR Clinical Trial

Public title

A Study to Evaluate the Suppression of Onset of Acute Upper Respiratory Tract Symptoms by the Consumption of a Test Food Product

Acronym

A Study to Evaluate the Suppression of Onset of Acute Upper Respiratory Tract Symptoms by the Consumption of a Test Food Product

Scientific Title

A Study to Evaluate the Suppression of Onset of Acute Upper Respiratory Tract Symptoms by the Consumption of a Test Food Product

Scientific Title:Acronym

A Study to Evaluate the Suppression of Onset of Acute Upper Respiratory Tract Symptoms by the Consumption of a Test Food Product

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A study to verify whether 12 weeks of continuous consumption of a test food product suppresses the onset of acute upper respiratory tract symptoms compared to a control food.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence rate of upper respiratory tract symptoms during the study period, based on the daily diary.

Key secondary outcomes

- Changes in plasmacytoid dendritic cell (pDC) activity
- Number of occurrences of upper respiratory tract symptoms during the trial, based on the daily diary.
- Duration of illness per occurrence of upper respiratory tract symptoms, based on the daily diary.
- Number of days from the start of the trial until the onset of upper respiratory tract symptoms, based on the daily diary.
- Salivary sIgA concentration and salivary sIgA secretion rate
- Severity score of 10 upper respiratory tract symptoms using the Japanese version of the WURSS-21 questionnaire.
- Total severity score of 10 upper respiratory tract symptoms using the Japanese version of the WURSS-21 questionnaire.
- Level of interference with health-related quality of life (9 items) using the Japanese version of the WURSS-21 questionnaire
- Total level of interference with health-related quality of life (9 items) using the Japanese version of the WURSS-21 questionnaire
- Incidence rate of adverse events and side effects

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral consumption of the test food, three times daily for 12 weeks.

Interventions/Control_2

Oral consumption of the placebo food, three times daily for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Healthy men and women aged 20 to below 60 years at the time of consent acquisition.
2. Subjects who perceive themselves as being prone to catching colds.
3. Subjects who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.

Key exclusion criteria

1. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), foods with functional claims, or health foods (including supplements) that claim to support immune function three or more times per week.
2. Subjects who cannot discontinue the consumption of Foods for Specified Health Uses (FOSHU), foods with functional claims, or health foods (including supplements) that claim to support immune function from the time of consent.
3. Subjects taking medications that may affect the trial (such as antibiotics, probiotics, or laxatives) and are unable to restrict use during the trial period.
4. Subjects who received a vaccine, such as the influenza or coronavirus vaccine, within six months prior to providing consent.
5. Subjects planning to receive the influenza or coronavirus vaccine after providing consent.
6. Subjects who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
7. Subjects with a habit of consuming 2 liters or more of tea beverages per day.
8. Subjects with excessive alcohol intake.
9. Subjects with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
10. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
11. Subjects with allergies to medications and/or food, especially tea.
12. Subjects who plan to take medication for seasonal allergies during the trial period (excluding temporary use of eye drops or nasal sprays).
13. Subjects who donated 200 mL of their blood or blood components within the last month.
14. Subjects who donated 400 mL of his blood within the last 3 months.
15. Subjects who donated 400 mL of her blood within the last 4 months.

Target sample size

72

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Mitsui Norin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

10

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

72

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2024

Year

09

Month

25

Day

Date of IRB

2024

Year

09

Month

20

Day

Anticipated trial start date

2024

Year

10

Month

05

Day

Last follow-up date

2025

Year

04

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
16. Subjects who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
17. Subjects who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
18. Subjects with a sensitivity to caffeine that causes adverse health effects.
19. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

(Sub group analysis)
Subgroup analysis will be conducted in a population excluding participants who contract influenza during the study period.

Registered date

2024

Year

10

Month

04

Day

Last modified on

2025

Year

06

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063477