UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the immune function

Acronym

Effects of consumption of the test food on the immune function

Scientific Title

Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled comparison trial

Scientific Title:Acronym

Effects of consumption of the test food on the immune function

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of 4-week consumption of the test food on the immune function

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured values of scoring of immunological vigor at four weeks after consumption (4w)

Key secondary outcomes

1. The amount of change of scoring of immunological vigor between screening (before consumption; Scr) and 4w

2. The measured values of immunological grade at 4w

3. The amount of change of immunological grade between Scr and 4w

4. The measured values of immunological vigor test^*1 and intestinal flora^*2 at 4w

5. The measured values of original questionnaires (the Likert scale method) at 4w

6. The amount of change of original questionnaires between Scr and 4w

7. The amount of change of immunological vigor test^*1 and intestinal flora^*2 between Scr and 4w

8. The ratio of subjects who were scored in each of the following items of immunological vigor at 4w: immunological grade, the score of T cells, the score of CD8⁺CD28⁺T cells, the score of ratio of CD4⁺/CD8⁺T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, and the score of NK cells

^*1 immunological vigor test
T lymphocyte age (upper limit), the score of T cells, the score of CD8⁺CD28⁺T cells, the score of ratio of CD4⁺/CD8⁺T cells, the score of naive T cells, the score of ratio of naive / memory T cells, the score of B cells, the score of NK cells, the number of T cells, the number of CD4⁺ cells, the number of CD8⁺ cells, the ratio of CD4⁺/CD8⁺T cells, the number of naive T cells, the ratio of naive / memory T cells, the number of B cells, the number of NK cells, the number of CD8⁺CD28⁺T cells

^*2 intestinal flora
Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium clusterXI, Clostridium subcluster XIVa, Clostridium cluster XVIII

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: The test foods 1, 2, and 3
Administration:
Morning: Take about 3 g of the test food 1, 6 g of the test food 2, and 30 mL of the test food 3 mixed with water (about 180 mL)
Daytime: Take about 3 g of the test food 1 mixed with water (about 180 mL) then take the same again more than two hours later
Night: Take about 3 g of the test food 1, 6 g of the test food 2, and 30 mL of the test food 3 mixed with water (about 180 mL)

* It does not matter if you take it before or after meals, right after waking up or right before bedtime.
* Daily dose should be taken in several parts within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Four weeks
Test food: The placebo foods 1, 2, and 3
Administration:
Morning: Take about 3 g of the placebo food 1, 6 g of the placebo food 2, and 30 mL of the placebo food 3 mixed with water (about 180 mL)
Daytime: Take about 3 g of the placebo food 1 mixed with water (about 180 mL) then take the same again more than two hours later
Night: Take about 3 g of the placebo food 1, 6 g of the placebo food 2, and 30 mL of the placebo food 3 mixed with water (about 180 mL)

* It does not matter if you take it before or after meals, right after waking up or right before bedtime.
* Daily dose should be taken in several parts within the day. If you forget to take the test food, take it as soon as you remember within the day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who feels tired easily

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects who have low scoring of immunological vigor at Scr

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Function Claims,"

5. Subjects who are currently taking medications (including herbal medicines) and supplements.

6. Subjects who are allergic to medicines and/or vegetables and fruits in general.

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

9. Subjects who are diagnosed with pollen allergy

10. Subjects who have an autoimmune disease

11. Subjects who are taking immunosuppressants such as steroids

12. Subjects who have received vaccination for infectious diseases such as influenza within three month

13. Subjects who are diagnosed with hemoglobinemia (iron overload)

14. Subjects who are diagnosed with Wilson's disease

15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Target sample size

20

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

BOTANIC LABORATORY Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2021

Year

06

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

22

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

2021

Year

05

Month

26

Day

Date of IRB

2021

Year

05

Month

26

Day

Anticipated trial start date

2021

Year

06

Month

03

Day

Last follow-up date

2021

Year

09

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

06

Month

02

Day

Last modified on

2022

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050718