UMIN-CTR Clinical Trial

Public title

Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.

Acronym

Study for evaluating the safety of excessive intake of food originated from a microorganism

Scientific Title

Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.

Scientific Title:Acronym

Study for evaluating the safety of excessive intake of food originated from a microorganism

Region

Japan

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of excessive intake of food originated from a microorganism.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. Interview by physician
2. Height and body weight
3. Blood pressure and pulse
4. Hematological test
5. Blood biochemical analysis
6. Urine analysis
7. Subjective symptom and objective response
8. Adverse events

Key secondary outcomes

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

Food originated from a microorganism. 5 portion of food per day for 4 weeks.

Interventions/Control_2

Placebo food, 5 portion of food per day for 4 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) Males and females aged from 20 to less than 65 years old, when giving the informed consent.
(2) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.

Key exclusion criteria

(1) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(2) Individuals who have chronic diseases and use medicines continuously.
(3) Individuals with excessive alcohol-drinking behaviors (Maximum daily quantity: Approximately 20 g of pure alcohol per day, for example, beer 1 bottle 500 mL, whiskey double 1 cup 60 mL, or wine approximately 1.5 cups 180 mL, respectively) .
(4) Individuals who cannot stop drinking for two days until the screening and each checkup.
(5) Individuals having food allergy.
(6) Individuals who have a medical history of hay fever.
(7) Individuals who have a medical history of diseases affecting digestion and absorption.
(8) Individuals who have tendency to get diarrhea by eating dairy product.
(9) Individuals who have a history of irritable bowel syndrome and Crohns disease.
(10) Individuals who are judged as unsuitable for the study based on the results of blood test.
(11) Individuals who have under treatment or a history of drug addiction and/or alcoholism.
(12) Individuals who are participating or willing to participate in other clinical trials with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products.
(13) Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
(14) Individuals who refuse to answer their biological sex.
(15) Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods.
(16) Individuals who are judged unsuitable for this study by the investigator for other reasons.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Satoru Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical Examination and Treatment Management Family

Zip code

Address

The 5th floor of Shinagawa season terrace, 1-2-70 Konan, Minato-ku, Tokyo, Japan

TEL

03-3452-3381

Email

satoru_suzuki@sempos.or.jp

Name of contact person

1st name
Middle name
Last name	Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales Department

Zip code

Address

The 7th floor of Shibaura omodaka building, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL

Email

yoshikawa@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2017

Year

05

Month

11

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

2017

Year

04

Month

25

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

11

Day

Last modified on

2017

Year

10

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031291