UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on immunity of healthy Japanese subjects

Acronym

Effects of consumption of the test food on immunity of healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on immunity of healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

Effects of consumption of the test food on immunity of healthy Japanese subjects

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 on immunity with the test food for four weeks in healthy Japanese adult subjects who are experiencing daily fatigue

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Scoring of immunological vigor

* Assess the measured value at screening (before consumption) and at four weeks after consumption.

Key secondary outcomes

1. Immunological age
2. T lymphocyte age
3. CD3⁺T cell ratio
4. CD4⁺T cell ratio
5. CD8⁺T cell ratio
6. Naive T cell ratio (CD4⁺)
7. Memory T cell ratio (CD4⁺)
8. CD8⁺CD28⁺T cell ratio
9. B cell ratio (CD20⁺)
10. NK cell ratio (CD56⁺16^-)
11. NK cell ratio (CD56⁺16⁺)
12. NK cell ratio (CD56^-16⁺)
13. Number of CD3⁺T cells
14. Number of CD4⁺T cells
15. Number of CD8⁺T cells
16. CD4⁺T cell/CD8⁺ T cell ratio
17. Number of naive T cells
18. Number of memory T cells
19. Naive T cell/memory T cell ratio
20. Number of B cells
21. Number of NK cells
22. T-cell proliferation index
23. T cell proliferative capacity
24. Immunological grade
25. Scoring of T cells
26. Scoring of T-cell proliferation index
27. Scoring of CD4 T cell/CD8 T cell ratios
28. Scoring of naive T cells
29. Scoring of naive T cell/memory T cell ratios
30. Scoring of B cells
31. Scoring of NK cells
32. Scoring of CD8⁺CD28⁺T cell ratios
33. Subjective symptoms (The Likert scale method)

*^1-33 Assess the measured value at screening (before consumption) and at four weeks after consumption.

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

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Tablets containing Corchorus olitorius L.
Administration: Take a total of 30 tablets per day between meals with water and no chewing

* 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: Placebo
Administration: Take a total of 30 tablets per day between meals with water and no chewing

* 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. Healthy Japanese adult subjects

2. Subjects who are experiencing daily fatigue

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

4. Subjects who have relatively low scoring of immunological vigor at screening (before consumption)

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", or other functional food/beverage in daily

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

6. Subjects who regularly use anticoagulants, such as warfarin

7. Subjects who are smokers

8. Subjects who are diagnosed with pollen allergy

9. Subjects who are allergic to medicines and/or the test food related products

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

11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period

12. 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	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

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

TEL

03-3818-0610

Email

kazu@orthomedico.jp

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

AOTSUBU CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara 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

info@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)

Date of disclosure of the study information

2019

Year

11

Month

25

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

http://www.newfoodindustry.com/cn7/2103.html

Number of participants that the trial has enrolled

22

Results

Nagahara H, Nagahara M, Ohmi N, Takahashi Y, Takara T. Effects of consumption of food containing Mulukhiyah (Corchorus olitorius; AOTSUBU) on immune function of healthy Japanese adults: a randomized, double-blind, placebo-controlled, parallel-group comparison study. New Food Industry. 2021; 63(3): 185-200

Results date posted

2021

Year

05

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

03

Month

01

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2019

Year

11

Month

19

Day

Date of IRB

2019

Year

11

Month

19

Day

Anticipated trial start date

2019

Year

11

Month

26

Day

Last follow-up date

2020

Year

03

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

11

Month

25

Day

Last modified on

2021

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044096