UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018783
Receipt number R000021727
Scientific Title Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine
Date of disclosure of the study information 2015/08/26
Last modified on 2021/03/02 20:00:10

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Basic information

Public title

Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine

Acronym

Safety and efficacy evaluation of drink with a plant-derived product and carnosine

Scientific Title

Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine

Scientific Title:Acronym

Safety and efficacy evaluation of drink with a plant-derived product and carnosine

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Test to evaluate safety and efficacy of 8-week-drinking with a plant-derived product and carnosine

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Number of adverse effects
Stress reaction

Key secondary outcomes

Number of adverse events
Proteins and chemicals in blood
Intestinal bacterial flora analysis


Base

Study type

Interventional


Study design

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 considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

One drink with plant-derived product and carnosine every day for eight weeks

Interventions/Control_2

One drink without plant-derived product and carnosine every day for eight 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Healthy males and females aged 20 to less than 65 years old.
2) Top 60 people detected as high stressor
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1) Subjects who take continuous medical treatment.
2) Subjects who have systolic blood pressure less than 90 mmHg.
3) Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman.
4) Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study.
5) Male subjects who donated 400 mL of blood within the last three months prior to the current study.
6) Female subjects who donated 400 mL of blood within the last four months prior to the current study.
7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
9) Subjects who are participating in other clinical studies, or who finished clinical study within three months.
10) Subjects who are contracting heart disease, liver disease, kidney disease and digestive disease.
11) Subjects who have contracted a disease in circulatory organs.
12) Subjects who have allergic reaction to drug medicine and food.
13) Subjects who drink alcohol or smoke a lot.
14) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
15) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Norihito
Middle name
Last name Murayama

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan

TEL

050-3182-0588

Email

Norihito_Murayama@suntory.co.jp


Public contact

Name of contact person

1st name Jiro
Middle name
Last name Takano

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0598

Homepage URL


Email

Jiro_Takano@suntory.co.jp


Sponsor or person

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name



Funding Source

Organization

Suntory Global Innovation Center Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clini

Address

2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.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

チヨダパラメディカルケアクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 26 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Unpublished


Result

URL related to results and publications

Unpublished

Number of participants that the trial has enrolled

60

Results

Unpublished

Results date posted

2021 Year 03 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Unpublished

Participant flow

Unpublished

Adverse events

Unpublished

Outcome measures

Unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 08 Month 18 Day

Date of IRB

2015 Year 08 Month 18 Day

Anticipated trial start date

2015 Year 08 Month 26 Day

Last follow-up date

2015 Year 11 Month 13 Day

Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 12 Month 04 Day

Date analysis concluded

2018 Year 12 Month 28 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 24 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021727


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name