UMIN-CTR Clinical Trial

Public title

Sensory testing of polyphenols in plant foods.

Acronym

Sensory testing of polyphenols in plant foods.

Scientific Title

Sensory testing of polyphenols in plant foods.

Scientific Title:Acronym

Sensory testing of polyphenols in plant foods.

Region

Japan

Condition

taste/olfactory

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Polyphenols in plant foods are known as flavour compounds such as colour, bitterness and astringency, and 8,000 species have been identified to date. On the other hand, consumption of polyphenol-rich foods has been shown to reduce the risk of cardiovascular disease and activate brain function. We have confirmed that when certain polyphenol compounds are ingested by animals and humans, various functions such as stimulation of the circulation and improvement of metabolism occur immediately afterwards, and that these physiological changes are responses mediated by activation of brain function. In addition, compounds with particularly strong activity are generally considered to have a "strong astringency", but there are very few cases of scientific verification. Therefore, in this study, a sensory test will be carried out on the taste quality of polyphenols. In addition, some polyphenols are ingested orally by animals. As the effect of maintaining alertness has been confirmed, we will also investigate changes in mood after oral intake.

Basic objectives2

Others

Basic objectives -Others

Some polyphenols are ingested orally by animals. As the effect of maintaining alertness has been confirmed, we will also investigate changes in mood after oral intake.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Taste

Key secondary outcomes

Mood

Study type

Interventional

Basic design

n-of-1

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Food

Interventions/Control_1

A polyphenol concentrate extracted from plant foods is diluted in three steps with commercially available mineral water and used as a test sample. The panelists hold the aqueous solution in their mouths for 10-20 seconds and then spit it out. They then answer the taste quality questionnaire. The testing schedule is to conduct the first test 60 minutes after the designated breakfast and the second test 1 hour after the designated lunch. Thirty minutes after the end of the one-course test, the panelists also answer a mood profile test (POMS; web version, manufactured by Kaneko Shobo Co., Ltd.).

Interventions/Control_2

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

40

years-old

>=

Gender

Male and Female

Key inclusion criteria

Subjects are selected as follows from a pool of panelist candidates (target 25) who have been informed of the test and have given their consent. Candidate panelists hold a solution of caffeine (standard for bitterness) or alum (standard for astringency) diluted in three steps for 10-20 seconds and then spit it out. They then answer the taste quality questionnaire. We select 10 panelists who are highly sensitive to bitterness and astringency.

Key exclusion criteria

Panelists with low sensitivity to bitterness and astringency.

Target sample size

10

Name of lead principal investigator

1st name	Naomi
Middle name
Last name	Osakabe

Organization

Shibaura Institue of Technology

Division name

College of System Engineering and Science

Zip code

3378570

Address

Fukasaku 307, Minumaku, Saitama, Saitama

TEL

0487206031

Email

nao-osa@shibaura-it.ac.jp

Name of contact person

1st name	Naomi
Middle name
Last name	Osakabe

Organization

Bioscience and Engineering

Division name

Food & Nutrition Laboratory

Zip code

3378570

Address

Fukasaku 307, Minumaku, Saitama, Saitama

TEL

048-720-6031

Homepage URL

Email

nao-osa@shibaura-it.ac.jp

Institute

Shibaura Institue of Technology

Institute

Department

Personal name

Organization

Shibaura Institue of Technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shibaura Institue of Technology

Address

Toyosu 3-7-5, Kotoku, Tokyo

Tel

03-5859-7340

Email

ykodama@ow.shibaura-it.ac.jp

Secondary IDs

YES

Study ID_1

23-010

Org. issuing International ID_1

Shibaura Institute of Technology Biotechnology Research Ethics Review Committee

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

18

Day

Date of IRB

Anticipated trial start date

2023

Year

11

Month

25

Day

Last follow-up date

2024

Year

12

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

21

Day

Last modified on

2023

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058939