UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015657
Receipt number R000018204
Scientific Title Effectiveness of "Taheebo" -containing food : a randomized, double blind, placebo-controlled study
Date of disclosure of the study information 2014/11/11
Last modified on 2015/06/08 17:10:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effectiveness of "Taheebo" -containing food : a randomized, double blind, placebo-controlled study

Acronym

Effectiveness of "Taheebo" -containing food

Scientific Title

Effectiveness of "Taheebo" -containing food : a randomized, double blind, placebo-controlled study

Scientific Title:Acronym

Effectiveness of "Taheebo" -containing food

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate improvement effect of ingestion of "Taheebo"-containing food for 12 consecutive weeks on antioxidative potency and immune strength for subjects who feel stress or tiredness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

antioxidative potency, immune strength

Key secondary outcomes

QOL, safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of "Taheebo"-containing food for 12 consecutive weeks

Interventions/Control_2

Ingestion of placebo (food without "Taheebo") for 12 consecutive 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

30 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Male and female between 30 and 59 years of age inclusive
2. Stress or tiredness

Key exclusion criteria

1. Subjects with food allergies
2. Subjects who are pregnant or lactating
3. Subjects who consume medicinal product which may influence the outcome of the study
4.Subjects who consume food which may influence the outcome of the study
5. Subjects who are judged as unsuitable for the study by the investigator for the other reason

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatomo Najima

Organization

Japan clinical trial assosiation

Division name

N.A.

Zip code


Address

3F, 3-2-27 nishishinjuku, shinjukuku, Tokyo

TEL

03-6729-0350

Email

info@yakujihou.org


Public contact

Name of contact person

1st name
Middle name
Last name Hirohisa Kojima

Organization

Japan clinical trial assosiation

Division name

N.A.

Zip code


Address

3F, 3-2-27 nishishinjuku, shinjukuku, Tokyo

TEL

03-6729-0350

Homepage URL


Email

info@yakujihou.org


Sponsor or person

Institute

Japan clinical trial assosiation

Institute

Department

Personal name



Funding Source

Organization

TAHEEBO JAPAN 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

2014 Year 11 Month 11 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

2014 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 11 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

2014 Year 11 Month 11 Day

Last modified on

2015 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name