UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a plant-derived ingredient containing food on lipid metabolism.
Title of the study (Brief title)	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	Noriko Osaki
Organization	Kao Corporation
Division name	R&D-Development Research-Healthcare Food Research
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	Toshitaka Sakuda
Organization	Kao Corporation
Division name	R&D-Development Research-Healthcare Food Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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