UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019645
Receipt number R000022703
Scientific Title Randomized controlled trial to detect effectiveness of caffeine for college students -part of the public health lectures and training in 2015-
Date of disclosure of the study information 2015/11/05
Last modified on 2016/09/12 19:12:32

* 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

Randomized controlled trial to detect effectiveness of caffeine for college students -part of the public health lectures and training in 2015-

Acronym

Coffee trial in public health class 2015

Scientific Title

Randomized controlled trial to detect effectiveness of caffeine for college students -part of the public health lectures and training in 2015-

Scientific Title:Acronym

Coffee trial in public health class 2015

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Detect efficacy of caffeine for university students

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Numbers of correct answers by summation carried out on a 10 by 10 grid of numbers in 2 minutes.
Difference between before and 30 min after drinking randomized allocated coffee or decaf.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

freeze dried instant coffee with caffeine
administration period:1day(1time)
dose:2g(with 140ml water)

Interventions/Control_2

freeze dried instant decaf coffee
administration period:1day(1time)
dose:2g(with 140ml water)

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

Male and Female

Key inclusion criteria

4th grade student belong school of medicine, Keio university

Key exclusion criteria

pregnant or probably pregnant women
lactating women
those who cannot drink coffee
those who never drank coffee
those who have a history of stomach ulcer
those who have a history of hyperacidity

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Takebayashi

Organization

Keio University

Division name

Department of Preventive Medicine and Public health, School of Medicine

Zip code


Address

35 Shinanomachi Shinjyuku-ku, Tokyo, Japan

TEL

0353633758

Email

ttakebayashi@a3.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ayano Takeuchi

Organization

Keio University

Division name

Department of Preventive Medicine and Public health, School of Medicine

Zip code


Address

35 Shinanomachi Shinjyuku-ku, Tokyo, Japan

TEL

0353633758

Homepage URL


Email

ayanotakeuchi@keio.jp


Sponsor or person

Institute

Department of Preventive Medicine and Public health, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University

Organization

Division

Category of Funding Organization

Other

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

2015 Year 11 Month 05 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

Primary endpoint was 2.049(caffeine group got more score than decaf group), P=0.1133.

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

2015 Year 10 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 11 Month 16 Day


Other

Other related information



Management information

Registered date

2015 Year 11 Month 05 Day

Last modified on

2016 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name