UMIN-CTR Clinical Trial

Public title

A verification study of enhancement of the immune system with ingestion of test food on healthy subjects: An open-label trial.

Acronym

A verification study of enhancement of the immune system with ingestion of test food on healthy subjects

Scientific Title

A verification study of enhancement of the immune system with ingestion of test food on healthy subjects: An open-label trial.

Scientific Title:Acronym

A verification study of enhancement of the immune system with ingestion of test food on healthy subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify enhancement of the immune system with the test food

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Scoring of immunological vigor
2. T lymphocyte age
3. T cells
4. CD4⁺/CD8⁺ T cells ratio
5. Naive T cells
6. Naive/memory T cells ratio
7. B cells
8. NK cells
9. CD8⁺CD28⁺ T cells
*^1-9Assess at 0 and 4 weeks after consuming

Key secondary outcomes

Subjective symptoms (The Likert scale method)
*Assess at 0 and 4 weeks after consuming

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test Food: Manda Koso
Dosage: Take 5 packs per day after breakfast. Take the packs with water as necessary.
* If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

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 adults who are experiencing daily fatigue
2. Subjects who are judged as eligible to participate in the study by the physician
3. Subjects who have 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 or 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 dietary supplements
6. Subjects who are allergic to medicines and/or the test food related products especially orange, walnut, sesame seed, soybean, banana, and apple
7. Subjects who are pregnant, breast-feeding, or planning to become pregnant
8. 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 participate another trial during this trial
9. Subjects who are ineligibility to participate in the study based on the evaluation of the physician

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

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
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

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

MANDA FERMENTATION 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

Address

Tel

Email

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

2018

Year

12

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

2018

Year

11

Month

28

Day

Date of IRB

2018

Year

11

Month

28

Day

Anticipated trial start date

2018

Year

12

Month

14

Day

Last follow-up date

2019

Year

03

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

13

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040083