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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036695
Receipt No. 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 2020/05/09

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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
Institute University of Kochi
Faculty of nutrition
Institute
Department

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 No longer recruiting
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 01 Month 30 Day
Last follow-up date
2019 Year 02 Month 10 Day
Date of closure to data entry
2019 Year 02 Month 28 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

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2020 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.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


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