UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026287
Receipt number R000030194
Scientific Title Effects of green tea and black tea extracts-containing dietary supplement intake on motor function : a randomized double-blind, parallel-group, placebo-controlled study
Date of disclosure of the study information 2017/02/24
Last modified on 2018/07/13 15:59:02

* 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

Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
: a randomized double-blind, parallel-group, placebo-controlled study

Acronym

Effects of green tea and black tea extracts-containing dietary supplement intake on motor function

Scientific Title

Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
: a randomized double-blind, parallel-group, placebo-controlled study

Scientific Title:Acronym

Effects of green tea and black tea extracts-containing dietary supplement intake on motor function

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verify the influence of dietary supplement intake on motor function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS (fatigue item, degree of fatigue recovery after exercise, etc.)

Key secondary outcomes

Lactic acid,red blood cell count,MCV,CK,

Inflammatory cytokines (IL-1beta, IL-6),
Salivary cortisol


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week continuous intake of green tea and black tea extracts-containing dietary supplement(low dose)

Interventions/Control_2

12-week continuous intake of green tea and black tea extracts-containing dietary supplement (high dose)

Interventions/Control_3

12-week continuous intake of placebo

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)30<=Age=<59 of healthy men and women

Key exclusion criteria

(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases
(2) Subjects who are likely to have allergic symptoms due to components contained in the test food
(3) Subjects who indicate disorder of heart and lung function
(4) Subjects who indicate abnormal parameter in liver or kidney function
(5) Subjects who had a gastrointestinal surgery
(6) Subjects with a disease under treatment now
(7) Subjects with drug or food allergy
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods
(10) Subject who consume exscessive alcohol
(11) Smoker.
(12) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(13) Subjects who is participating in the other study or plannning to participate during the study period
(14) Subjects who isdeemed unsuitable by the principal investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Wakame

Organization

Hokkaido Pharmaceutical University School of Pharmacy

Division name

Pharmacology

Zip code


Address

Maeda,Teine-ku,Sapporo,Hokkaido,006-8590

TEL

011-676-8682

Email

wakame-k@hokuytakudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code


Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-4801-8917

Homepage URL


Email

mterashima@oneness-sup.co.jp


Sponsor or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name



Funding Source

Organization

WAKASA SEIKATSU Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Institute of Fitness and Sports in Kanoya

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

2017 Year 02 Month 24 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 01 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 27 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

2017 Year 02 Month 24 Day

Last modified on

2018 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030194


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name