UMIN-CTR Clinical Trial

Public title

Effect of black tea consumption on flow mediated dilatation: A randomized, placebo controlled, double blind, crossover trial.

Acronym

Effect of black tea consumption on flow mediated dilatation

Scientific Title

Effect of black tea consumption on flow mediated dilatation: A randomized, placebo controlled, double blind, crossover trial.

Scientific Title:Acronym

Effect of black tea consumption on flow mediated dilatation

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the alteration of flow mediated dilatation after ingestion of black tea which is rich in theaflavin compared with placebo drink in healthy volunteers, by the method of randomized, placebo controled, double blind, crossover trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

FMD

Key secondary outcomes

Blood Nitrate/Nitrite concentration
Blood catechole amine concentration

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

FMD analysis and blood sampling is carried out before intake of black tea, 2 and 4 hours after intake of drink

Interventions/Control_2

FMD analysis and blood sampling is carried out before intake of placebo drink, 2 and 4 hours after intake of drink

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Subjects aged 20 through 65 years
2) Subjects whose systolic blood pressure below 150 mmHg
3) Subjects who have not taken alcohol drink the day before
4) Subjects are competent to consent

Key exclusion criteria

1) Subjects who is currently taking medication for hypertension
2) Subjects who take any supplement, functional food, tea or chocolate during the test period.
3) Subjects who drink more than 25 g/day of alcohol
4) Subjects who has sports habit.
5) Subjects with diabetes, renal disease, or hepatic disease
6) Subjects with a diagnosis of familial hypertension
7) Subjects with any history for alimentary allergy
8) Subjects who is pregnant, plan to get pregnant between trial period, is during lactation.
9) Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Tsutomu Nakayama

Organization

Nippon Veterinary and Life Science University

Division name

Faculty of Applied Life Science

Zip code

Address

1-7-1 Minamimachi, Musashinoshi, Tokyo, Japan

TEL

0422-51-6121

Email

nakayama@nvlu.ac.jp

Name of contact person

1st name
Middle name
Last name	Naomi Osakabe

Organization

Shibaura Institute of Technology

Division name

Faculaty of System Engineeringand Science

Zip code

Address

307 Fukasaku, Minumaku, Saitama, Japan

TEL

048-720-6031

Homepage URL

Email

nao-osa@sic.sibaura-it.ac.jp

Institute

Shizuoka Industrial Foundation

Institute

Department

Personal name

Organization

Japan Society and Technology Agency

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

NTT西日本高松診療所　予防医療センタ

Date of disclosure of the study information

2013

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

According to the protocol, all 15 subjects were conducted the present study. The data of 14 subjects except one subject who infringed of the exclusion criterion were analyzed. FMD, as primary end point, was significantly high level in test drink group compared with placebo group 240 min after ingestion. After calculation of the 95 percent confidence limit using before treatment value of the al subject, the data of 10 subject whose FMD was within the 95 percent confidence limit before treatment were analyzed, FMD was significantly elevated 120 min after ingestion of test drink compared with before treatment. Nitrate and nitrite or catecholamine levels in blood, as secondary end points, were not observed any difference between experimental groups. Systolic and diastolic blood pressure were significantly increased 120 and 240 min after ingestion of test drink compared with before treatment.

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

09

Month

19

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

27

Day

Last modified on

2014

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013866