UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the physical condition and the immune function of healthy subjects

Acronym

Effects of consumption of the test food on the physical condition and the immune function of healthy subjects

Scientific Title

Effects of consumption of the test food on the physical condition and the immune function of healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison trial

Scientific Title:Acronym

Effects of consumption of the test food on the physical condition and the immune function of 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 the effects of eight-week consumption of the test food on the physical condition and the immune function of the subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The Questionnaire concerning the physical condition

Key secondary outcomes

1. The Questionnaire concerning the physical condition (Items excluding the primary outcome)
2. Immune functions
3. Diary questionnaires

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: Eight weeks
Test food: Active food
Administration: Take two packs per day (one pack each after breakfast and dinner with half a glass of water).

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo
Administration: Take two packs per day (one pack each after breakfast and dinner with half a glass of water).

*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 easy to get tired and sick
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who have relatively high scoring of FI at screening

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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5.Subjects who eat foods highly containing lactic acid bacteria such as lactic acid bacteria beverages and fermented foods more than two days per week
6.Subjects who eat foods highly containing collagen and/or gelatin such as beef sinew, liver, offal (motsu or horumon), pig's feet, chicken leg, chicken wing, chicken skin, chicken gristle (nankotsu), fish skin, conger pike (hamo), eel, anglerfish, jellied broth (nikogori), collagen-nabe, gelatin, gummi, and marshmallow more than two days per week
7.Subjects who are currently taking medications (including herbal medicines) and supplements
8.Subjects who are allergic to medicines and/or the test food-related products. Particularly allergic to fish, collagen, and gelatin.
9.Subjects who have a pollen allergy
10.Subjects who have received vaccination for infectious diseases such as influenza within a year before the agreement to participate in this trial
11.Subjects who are smokers, or started smoking cessation within a year before the agreement to participate in this trial
12.Subjects who are pregnant, lactating, or planning to become pregnant
13.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
14.Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60

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

Nippi, 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

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

66

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

2020

Year

10

Month

27

Day

Date of IRB

2020

Year

10

Month

27

Day

Anticipated trial start date

2020

Year

10

Month

30

Day

Last follow-up date

2021

Year

04

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

10

Month

30

Day

Last modified on

2021

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048280