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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020151
Receipt No. R000023275
Scientific Title Effect of a plant-derived ingredient containing food on lipid metabolism.
Date of disclosure of the study information 2015/12/18
Last modified on 2019/01/31

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Basic information
Public title Effect of a plant-derived ingredient
containing food on lipid metabolism.
Acronym Efflcacy of a plant-derived ingredient
containing food for postprandial
lipid metabolism.
Scientific Title Effect of a plant-derived ingredient
containing food on lipid metabolism.
Scientific Title:Acronym Efflcacy of a plant-derived ingredient
containing food for postprandial
lipid metabolism.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of single
ingestion of a plant-derived
ingredient containing a food on
postprandial lipid metabolism in
healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 8 hours of postprandial fat oxidation measurement by human calorimeter.
Key secondary outcomes 8 hours of postprandial energy expenditure and respiratory quotient measurement by human calorimeter.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of plant-derived ingredient containing food (test food code: A001)->washout->Single ingestion of plant-derived ingredient not containing food (control food code: P001).
Interventions/Control_2 Single ingestion of plant-derived ingredient not containing food (control food code: P001))->washout->Single ingestion of plant-derived ingredient containing food (test food code: A001).
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
24 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy males and females.
Key exclusion criteria 1. difficult to participate the study due to dysfunctions liver, or the other dysfunctions.
2. experienced a seizures based on circulatory-diseases before, or is under treatment.
3. arrhythmic.
4. who takes medication for glucose or fat metabolism, or hypertention.
5. who have experienced a seizures based on neural disease.
6. who was given surgery for a disease or an injury 2 months prior to the study.
7. who was given gastrectomy and/or bypass of part of the intestine.
8. who have allergic reaction for food.
9. Individual experienced unpleasant feeling during blood drawing.
10. claustrophobia.
11. insomnia.
12. chronic headache (migraine, tension headache, cluster headache, etc. ).
13. Person who donated more than 200mL of blood within a month, or more than 400mL within three months prior to informed consent.
14. who sleep habitually after 1:00 a.m. on weekday.
15. Heavy smoker
16. who had a weight change of more than +-2.0 kg for one month prior to informed consent.
17. who is engaged in night work and shift operations for more than 3 months prior to informed consent.
18. who is pregnant or expecting pregnancy.
19. who habitually take the foods for specified health uses (FOSHU) or functional food which solicits body fat reduction and absorption suppression of lipid or the carbohydrates (except for person who can stop consume them after informed consent.).
20. who can't accept doctor to check health condition, accessing the health examination result for the past two years, prior to the study.
21. who can't disclose age, the latest health examination result.
22. who can't reply to the questionnaire about living situation and condition.
23. who cannot indicate a menstruation situation.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Osaki
Organization Kao Corporation
Division name R&D-Development Research-Healthcare Food Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 1318501, JAPAN
TEL 03-5630-7224
Email osaki.noriko@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshitaka Sakuda
Organization Kao Corporation
Division name R&D-Development Research-Healthcare Food Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 1318501, JAPAN
TEL 03-5630-7456
Homepage URL
Email sakuda.toshitaka@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Self funding
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 花王株式会社ヘルスケア食品研究所(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 21 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
2015 Year 12 Month 10 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023275

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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