UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of repeated intake of the plant-derived processed food on postprandial fat oxidation.
Title of the study (Brief title)	Effect of the plant-derived processed food on postprandial fat metabolism in human subjects.
Region	Japan

Condition
Condition	Nothing (healthy subjects)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of repeated intake of the plant-derived processed food on postprandial fat oxidation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial fat oxidation
Key secondary outcomes	Postprandial respiratory quotient, Postprandial energy expenditure.

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	intake test diet (product code: A-001) for 2 weeks (one serving size per day) > wash out more than 2 weeks > intake control diet (product code: C-001) for 2 weeks (one serving size per day)
Interventions/Control_2	intake control diet (product code: C-001) for 2 weeks (one serving size per day) > wash out more than 2 weeks > intake test diet (product code: A-001) for 2 weeks (one serving size per day)
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	60 years-old >
Gender	Male
Key inclusion criteria	1. Subjects who are male and belong to KAO Corporation. 2. Age>=25 and <65 years 3. Subjects who can approve their medical record access and agree with the study protocol following explanation of current study. 4. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1. Subjects having a liver, kidney, or heart disease, respiratory disorder, endocrine disorder, metabolic disorder, nervous disorder, consciousness disorder, diabetes, or other diseases. 2. Subjects who have surgical history for disease or injury within the last two months prior to the current study. 3. Subjects who were experienced unpleasant feeling during blood collection or energy expenditure analyzing (metabolic chamber, hood, or mask). 4. Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the current study. 5. Subjects who take a medicine for hyperglycaemia, lipidemia, or hypertension. 6. Subjects whose visceral fat area is below 25 cm2. 7. Subjects whose energy expenditure is not stable. 8. Subjects who drink a lot of alcohol. (more than 30 g/day alcohol) 9. Subjects who habitually take the foods for specified health uses (FOSHU), functional food, or dietary supplements (capsules) affecting current study (e.g. fat weight, serum lipid level). (except for subjects who can stop consume them after informed consent) 10. Subjects whose weight change more than 2 kg during past 2 months. 11. Subjects who will plan to go long term business trip or travel (more than 5 days) during current study. 12. Subjects who have allergy against rubber. 13. Subjects who are not used to intake test diet. 14. Subjects who are smoker. 15. Subjects who have possibility for allergic reaction to food. 16. Subjects who can not intake test diet during clinical study period. 17. Subjects who have participated in other clinical study or are planned to participate in other clinical study. 18. Subjects who are judged to be inappropriate for the study based on the access record by medical doctor. 19. Subjects judged as unsuitable for the study by the investigator or medical doctor for other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	Noriko Osaki
Organization	Kao Corporation
Division name	Health Care Food Research
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	+81-3-5630-7224
Email	osaki.noriko@kao.co.jp

Public contact
Name of contact person	Yasutoshi Ando
Organization	Kao Corporation
Division name	Health care food Research center
Address	2-1-3, Bunka, Sumida-ku, Tokyo
TEL	+81-3-5630-7476
Homepage URL
Email	andou.yasutoshi@kao.co.jp

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)

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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 29 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 08 Month 25 Day
Anticipated trial start date	2015 Year 09 Month 01 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	Nineteen healthy subjects participated in this study, and postprandial energy metabolism was evaluated using indirect calorimetry followed by 14-d repeated pre-consumption of TAG (rapeseed oil) as a control or ALA-DAG. As a primary outcome, ALA-DAG induced significantly higher postprandial fat oxidation than TAG. As a secondary outcome, carbohydrate oxidation tended to be decreased. In addition, postprandial energy expenditure was significantly increased by ALA-DAG compared to TAG. These findings suggest that daily ALA-DAG consumption stimulates dietary fat utilization as energy after a meal, as well as greater diet induced thermogenesis in healthy humans. In conclusion, repeated consumption of ALA-DAG enhanced postprandial fat metabolism after a meal, which may partially explain its visceral fat area-reducing effect.
Other related information

Management information
Registered date	2015 Year 08 Month 28 Day
Last modified on	2016 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021490