UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for an effect of dietary fat oxidation after repeated ingestion of the plant-derived processed food.
Title of the study (Brief title)	Effect of the plant-derived processed food on dietary fat metabolism.
Region	Japan

Condition
Condition	Nothing (healthy subjects)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Dietary fat oxidation after 28 days repeated ingestion (breath analysis data)
Key secondary outcomes	Basal metabolic rate, Postprandial energy expenditure, Postprandial total fat oxidation, Postprandial respiratory quotient.

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 28 days (one serving size per day) > wash out more than 28 days > intake control diet (product code: C-001) for 28 days (one serving size per day)
Interventions/Control_2	Intake control diet (product code: C-001) for 28 days (one serving size per day) > wash out more than 28 days > intake test diet (product code: A-001) for 28 days (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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Age>=35 and <65 years 2.BMI>=23 and < 30 kg/m2 3.Person who provides informed consent by a document.
Key exclusion criteria	1.Person who is difficult to participate the study due to presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases. 2.Person who has skin infection or dysfunction on abdominal. 3.Person who has constipation more than 5 days. 4.Person whose waist circumference is less than 55 cm or more than 140 cm. 5.Person who has surgical or treatment history for disease or injury within two months before the trial. (except for common cold, abdominal pain, allergic rhinitis) 6.Person who taking medicine for hyperglycaemia, lipid metabolism, or hypertension. 7.Person who experienced unpleasant feeling during drawing blood. 8.Person who has donated 200 mL or more blood within one month before the trial. 9.Person who has possibility for allergies to ingredients in the test food or equipment used for indirect calorimetry. 10.Person whose weight changes more than +-5 kg within one month before the trial. 11.Person who is shift worker. 12.Person who planned business trip lasting 5 consecutive days or more. 13.Person who habitually takes the FOSHU (foods for specified health uses), functional food, or dietary supplements affecting current study (e.g. serum cholesterol, serum triglyceride, fat weight, blood glucose). (Except for person who can stop consume them after informed consent). 14.Person who inability or unwillingness to conform to the alcohol limitation (more than 30 g/day alcohol). 15.Person who inability or unwillingness to record diary during current study. 16.Person who inability or unwillingness to record daily diet during current study. 17.Person who is smoker. 18.Person who participating or planning to participate in other clinical studies. 19.Person who can't agree current informed consent. 20.Person who determined to be unqualified by the supervising physician based on the medical record or other reasons.
Target sample size	20

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	+81-3-5630-7266
Email	osaki.noriko@kao.co.jp

Public contact
Name of contact person	Shinpei Tomita
Organization	New drug research center Co. Ltd
Division name	Research Division
Address	452-1, Toiso, Eniwa-shi, Hokkaido
TEL	+81-123-34-0412
Homepage URL
Email	s-tomita@ndrcenter.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	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026219