UMIN-CTR Clinical Trial

Public title

A Study to Evaluate the Effect of Test Food Consumption on Subjective physical symptoms in Healthy Adults

Acronym

A Study to Evaluate the Effect of Test Food Consumption on Subjective physical symptoms in Healthy Adults

Scientific Title

A Study to Evaluate the Effect of Test Food Consumption on Subjective physical symptoms in Healthy Adults

Scientific Title:Acronym

A Study to Evaluate the Effect of Test Food Consumption on Subjective physical symptoms in Healthy Adults

Region

Japan

Condition

Healthy adults (Male/female)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the effect of the test food consumption on subjective physical symptoms in healthy adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cumulative number of days with reported symptoms during the consumption period, based on the self-reported physical condition questionnaire.

Key secondary outcomes

pDC activity (fluorescence intensity of CD86, HLA-DR, CD40, CD80), proportion of positive cells (pDCs as a percentage of monocytes, percentage of CD86+, HLA-DR+, CD40+, CD80+ among pDCs), IFN-alpha levels.

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 (1 bottle, once daily) for 12 weeks

Interventions/Control_2

Oral consumption of the placebo food (1 bottle, once 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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese men and women aged 20 to below 65 years at the time of consent acquisition.
2. Participants who are aware of that they are prone to catching colds.
3. Participants who are able to agree to participate in this study with a written document after receiving a detailed explanation of the protocol and understanding its contents.

Key exclusion criteria

1. Participants who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health foods (including supplements) three or more times per week.
2. Participants who are unable to discontinue the consumption of Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health foods (including supplements) from the time of consent acquisition.
3. Participants taking medications (such as antibiotics, intestinal regulators, laxatives, etc.) that are considered to potentially affect the study and are unable to restrict their use during the study period.
4. Participants 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.
5. Participants with excessive alcohol intake.
6. Participants who are unable to discontinue the consumption of foods containing a large amount of lactic acid bacteria or bifidobacteria (such as yogurt, lactic acid drinks, fermented pickles including kimchi and nukazuke made with lactic acid bacteria, but excluding unfermented pickles like salt-pickled vegetables) from the time of consent acquisition until the end of the study.
7. Participants who are aware of having hay fever, regularly taking or using medications for hay fever every year (excluding eye drops), or planning to use such medications during the study period.
8. Night shift workers.
9. Heavy smokers (21 or more cigarettes per day).
10. Participants planning to receive vaccinations (for influenza, COVID-19, etc.) from the time of consent acquisition until the end of the study.
11. Participants planning to travel overseas between the time of consent acquisition and the end of the study.
12. Participants with chronic diseases such as diabetes, hypertension, or dyslipidemia, who are regularly taking medications.
13 Participants who are prone to diarrhea after consuming dairy products.

Target sample size

200

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

MEGMILK SNOW BRAND 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

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

200

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

Completed

Date of protocol fixation

2024

Year

10

Month

21

Day

Date of IRB

2024

Year

10

Month

18

Day

Anticipated trial start date

2024

Year

10

Month

26

Day

Last follow-up date

2025

Year

05

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
14. Participants with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
15. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
16. Participants with allergies to medications and/or food.
17. Participants who donated 200 mL of their blood or blood components within the last month.
18. Males who donated 400 mL of his blood within the last 3 months.
19. Females who donated 400 mL of her blood within the last 4 months.
20. Males who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
21. Females who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
22. Participants deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Registered date

2024

Year

10

Month

25

Day

Last modified on

2025

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063766