UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036695
Receipt number R000035458
Scientific Title Study on body temperature and blood flow after ingesting ginger hot water
Date of disclosure of the study information 2019/05/09
Last modified on 2023/05/12 09:40:26

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Basic information

Public title

Study on body temperature and blood flow after ingesting ginger hot water

Acronym

Study on body temperature change and blood flow change after ingesting ginger hot water

Scientific Title

Study on body temperature and blood flow after ingesting ginger hot water

Scientific Title:Acronym

Study on body temperature change and blood flow change after ingesting ginger hot water

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to calify the influence on body temperature and blood flow after a single oral intake of ginger-Influence on body temperature and blood flow after a single oral intake of ginger-processed beverage powder containing 1.5 mg / 1 cup (18 g of powder) of 6-gingerol, for healthy Japanese males and females between 20 and 60 years old , the evaluation test is set up.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in body temperature and change in blood flow rate after 80 minutes of single drinking beverage measurement

Key secondary outcomes


Measurement of change in body temperature and change in blood flow after 80 minutes of single dose administration of beverage, measurement of change in blood pressure



















Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consume a drink containing the target food in hot water (120 ml) once a day.

Interventions/Control_2

Consume a drink in which test food (ginger processed product and water soluble polysaccharide) suspended in hot water (120 ml) once a day.

Interventions/Control_3

Consume a test food (ginger processed product and sugar suspended in hot water (120 ml) once a day.

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

1) A person who signed a written consent form
2) Healthy Japanese men and women aged between 20 and 60

Key exclusion criteria

1) Persons who do not have medical history of high blood pressure or food allergy
2) Medical institutions receive medical treatment for some reason within one week of each administration test, those who do not take medication within one week after the administration test

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Watanabe

Organization

University of Kochi

Division name

Faculty of nutrition

Zip code

781-8515

Address

2751-1, Ike, Kochi 781-8515, Japan

TEL

088-847-8598

Email

watana@cc.u-kochi.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Watanabe

Organization

University of Kochi

Division name

Faculty of nutrition

Zip code

7818515

Address

2751-1, Ike, Kochi 781-8515, Japan

TEL

088-847-8590

Homepage URL


Email

watana@cc.u-kochi.ac.jp


Sponsor or person

Institute

University of Kochi
Faculty of nutrition

Institute

Department

Personal name



Funding Source

Organization

KYOWA Corporation
Department of Product Development

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

University of Kochi

Address

Ike2751-1 Kochi

Tel

088-847-8590

Email

watana@cc.u-kochi.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

85

Org. issuing International ID_1

Japan Society of Nutrition and Food Science

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

高知県立大学(高知県)


Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 09 Day


Related information

URL releasing protocol

Hyperthermic response and its physiology-like effect by ingestion of processed ginger.

Publication of results

Unpublished


Result

URL related to results and publications

Hyperthermic response and its physiology-like effect by ingestion of processed ginger.

Number of participants that the trial has enrolled

49

Results

Back surface temperature changes, palm surface temperature changes, and blood flow changes were all significantly greater for ginger and polydextrose (G group) and ginger and sugars (S group) than those for polydextrose (P group).For all question items, the assessment values were significantly higher after ingestion than before for ginger and polydextrose (G group) and ginger and sugars (S group).

Results date posted

2020 Year 05 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants were invited by the poster attached to Kochi Prefectural University and local public facilities. Participation conditions were healthy males and females aged 20 to less than 60 years old, with no history of food allergy or hypertension, no chronic illness during medication. In addition, those who can come to Kochi Prefectural University Ike Campus from their home within 1 hour by bicycle, motorcycle, car or public transportation and have a regular health examination every year.

Participant flow

Drinking of alcohol on the day before the administration test was prohibited. The subject ate the processed food to be distributed and white rice for breakfast on the day. The subject urinated 40 minutes before the administration test and entered the test room. The subject's physical condition was checked and confirmed by the responsible doctor. Here, the male took off the underwear of the upper half of the body, the female took off the underwear of the upper half of the body other than the brassiere, put on a jacket that can be opened from above, sat in a chair, and waited.

Adverse events

Nothing was recognized

Outcome measures

(1) The temperature of the back of the hand was measured by thermography after waiting for 40 minutes. For the surface temperature of the palm, the average temperature of the entire back surface of the hand was used as the palm surface temperature.
(2) The jacket was taken off, and the temperature of the back surface was measured using a high-performance small thermal imaging camera. Regarding the surface temperature of the back, the average surface temperature of the region between the left and right shoulder blades with a width of 20 cm and a length of 30 cm was taken as the back surface temperature.
(3) Blood flow measurement
Measured by using a laser blood flow meter (, and by adhering a blood flow measurement probe to the skin that is in contact with the blood vessel part of the neck.
(4) Questionnaire evaluation
The same procedure for measuring body temperature and blood flow was used for each subject. Regarding the subjective physical condition before and after ingesting the test beverage, the test subjects had nine items: stiff shoulder, swelling of limbs, back temperature, chest temperature, hand temperature, foot temperature, fatigue, stress, and mood. , 7-point method was used to obtain a response, and a questionnaire survey was conducted.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 23 Day

Date of IRB

2018 Year 01 Month 22 Day

Anticipated trial start date

2018 Year 02 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 05 Month 20 Day


Other

Other related information

Hyperthermic response and its physiology-like effect by ingestion of processed ginger.
Hiroyuki Watanabe, Mamoru Tanaka, Satoshi Numata, Yuichiro Takei, Go Yokokawa, Takahiro Yoshimoto
J Jpn Mibyou Assoc, 26(2), 21-27, 2020.


Management information

Registered date

2019 Year 05 Month 09 Day

Last modified on

2023 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035458


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name