UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029058
Receipt number R000033235
Scientific Title Safety evaluation of excessive intake of yogurt , in adult men and women
Date of disclosure of the study information 2018/11/18
Last modified on 2019/11/27 16:42:56

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Basic information

Public title

Safety evaluation of excessive intake of yogurt , in adult men and women

Acronym

Safety evaluation of excessive intake of yogurt , in adult men and women

Scientific Title

Safety evaluation of excessive intake of yogurt , in adult men and women

Scientific Title:Acronym

Safety evaluation of excessive intake of yogurt , in adult men and women

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of yogurt drink containing lactic acid bacteria LH strain, 3-fold quantity of recommended daily intake.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of the test product for 4 weeks

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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Subjects aged from 20 to 64 years old
(2)Subjects about 10 people with negative for specific IgE(RAST)against house dust and mite.
(3)Subjects about 10 people with discomfort of eyes and nose(sneeze, runny nose, nasal) and positive for specific IgE (RAST) against house dust and mite.

Key exclusion criteria

(1)Subjects visiting the hospital for discomfort of eyes and nose or medicines affecting the test result
(2)Subjects who have history of regular visits of otorhinolaryngology or planned to clinic visits
(3)Subjects with acute rhinitis, sinusitis or hypertrophic rhinitis
(4)Subjects with bronchial asthma
(5)Subjects with allergies to the test food in the study
(6)Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function
(7)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9)Subjects who have participated in other clinical studies
(10)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(11)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(12)Subjects who are judged as unsuitable for the study by the investigator for other reason

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujta

Organization

MEGMILK SNOW BRAND Co.,Ltd.

Division name

Milk Science Research Institute Food Function Laboratory

Zip code


Address

1-1-2 Minamidai,Kawagoe,Saitama, Japan

TEL

049-242-8111

Email

tfujita@meg-snow.com


Public contact

Name of contact person

1st name
Middle name
Last name Chiharu Goto

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

c.goto@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

MEGMILK SNOW BRAND 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


Address


Tel


Email



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 11 Month 18 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

2017 Year 08 Month 18 Day

Date of IRB

2017 Year 08 Month 18 Day

Anticipated trial start date

2017 Year 09 Month 10 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 08 Day

Last modified on

2019 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name