UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034450
Receipt No. R000039285
Scientific Title A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function
Date of disclosure of the study information 2018/10/18
Last modified on 2019/01/07

* 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 A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function
Acronym Effect of plant-derived ingredient on body temperature and blood vessel function
Scientific Title A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function
Scientific Title:Acronym Effect of plant-derived ingredient on body temperature and blood vessel function
Region
Japan

Condition
Condition Nothing (Healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the food containing plant-derived ingredient on body temperature and blood vessel function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body temperature after 21 days repeated ingestion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Repeated intake active food (product code:A-001) once a day for 21 days.
Interventions/Control_2 Repeated intake placebo food (product code:B-001) once a day for 21 days.
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
25 years-old <=
Age-upper limit
59 years-old >=
Gender Male
Key inclusion criteria 1.Healthy men
2.Age>=25 and <60 years
Key exclusion criteria 1.Person who is presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases.
2.Person who has surgery within 2 months before the trial.
3.Person who has donated over 200 mL blood within one month or over 400 mL blood within three months before the trial.
4.Person who taking medications for hyperglycaemia, lipid metabolism, or hypertension.
5.Person whose SBP is over 160 mmHg or DBP is over 100 mmHg.
6.Person who taking supplements or foods that affect this trial (serum triacylglycerol, blood glucose, blood pressure, serum cholesterol, body fat).
7.Person who changes in body weight of => 3.0 kg within 1 month before the trial.
8.Person who is smoker.
9.Person who has allergies to food.
10.Person who participating or planning to participate in other clinical trial.
11.Person who can't agree informed consent.
12.Person who are judged to be inappropriate for current trial by the supervising physician or principal investigator for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Saito
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7456
Email saito.shinichiro@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasutoshi Ando
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7476
Homepage URL
Email andou.yasutoshi@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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
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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 18 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
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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 11 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.