UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032409
Receipt number R000036958
Scientific Title The effect confirmation study of usual consumption of test food - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults -
Date of disclosure of the study information 2018/05/02
Last modified on 2020/10/09 11:16:37

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Basic information

Public title

The effect confirmation study of usual consumption of test food - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults -

Acronym

The preliminary effect verification of consumption of the test food which contain lactic acid bacteria

Scientific Title

The effect confirmation study of usual consumption of test food - a preliminary verification of the effect of the test food which contain lactic acid bacteria for healthy adults -

Scientific Title:Acronym

The preliminary effect verification of consumption of the test food which contain lactic acid bacteria

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Exploratory verification of effect of the test food, when consume usual amount for a certain period.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency

Key secondary outcomes

Body Mass Index
Condition of facial skin
Microbiota of intestine
Productive availability of equol


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Preliminary test - the test before consumption of the test food - consumption of the usual amount of test food for 8 weeks and the test every week - the test after quit consumption of the test food.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Female

Key inclusion criteria

(1)Japanese healthy females aged 20 to 60 years old when consent acquisition.
(2)Females who don't be given treatment by taking medicines, therapies and/or operations even seasonal, chronic or sudden case.
(3)Females who show enough understanding of the clinical study procedures, and who agree with participating in the study by written informed consent from their own will.
(4)Females those BMI are 18.5 to less than 30.0.
(5)Females whose blood pressure (average from two times measurements) are within the conditions below.
Systolic blood pressure is less or equal 139 mmHg.
Diastolic blood pressure is less or equal 89 mmHg.
(6)Females whose pulses are 40 to 100 times per minute.
(7)Females whose body temperatures are 35.5 to 37.0 degrees Celsius.
(8)Females who can prohibit excessive exercise during test period.
(9)Females who basically take 3 meals a day and can prohibit drinking and eating too much.
(10)Females who can contraception properly during test period.
(11) Females who can understand and compliance to controlled matters.

Key exclusion criteria

(1) Females who have disorder that affect absorption, distribution, metabolism and/or excretion of test food, such as disease in digestive tract, liver, kidney, heart and/or circulation system.
(2)Females who have surgery history in digestive tract such as gastrectomy, gastrointestinal suture surgery and/or intestinal resection etc., but except polypectomy and appendectomy.
(3)Females who have medical history of cerebral vascular disorder.
(4)Females who have specific constitution that occur allergy and/or hypersensitivity against test food.
(5) Females who suspect to alcohol dependence and/or drug dependence.
(6) Females who have attended other clinical trial and/or clinical study within 84 days before consent acquisition.
(7) Females who have done 400mL of whole blood donation within 84 days before consent acquisition. Females who have done 200mL of whole blood donation within 28 days before consent acquisition. Females who have done 200mL of ingredient donation within 14 days before consent acquisition.
(8)Females who are lactating and/or pregnant.
(9) Females who engage in mid-night work.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Toshio
Middle name
Last name Nishida

Organization

Tokai Gakuen University

Division name

School of Health and Nutrition

Zip code

468-8514

Address

2-901 Nakahira, Tenpaku-ku, Nagoya-city, Aichi, 468-8514, JAPAN

TEL

052-801-1472

Email

nishid-y@tokaigakuen-u.ac.jp


Public contact

Name of contact person

1st name Atsuhisa
Middle name
Last name Nishimura

Organization

ICHIBIKI CO., LTD.

Division name

Research Laboratory

Zip code

441-8019

Address

110-2 Kinuta, Hanada-cho, Toyohashi-city, Aichi, 441-8019, JAPAN

TEL

0532-32-3631

Homepage URL


Email

technicalcenter@ichibiki.co.jp


Sponsor or person

Institute

Tokai Gakuen University

Institute

Department

Personal name



Funding Source

Organization

ICHIBIKI CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee of Tokai Gakuen University

Address

2-901 Nakahira, Tenpaku-ku, Nagoya-shi, Aichi 468-8514, Japan

Tel

052-801-1201

Email

nishid-y@tokaigakuen-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 27 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036958


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name