UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a plant-derived processed food on fat metabolism
Acronym	Effect of a plant-derived processed food on dietary fat oxidation
Scientific Title	Effect of a plant-derived processed food on fat metabolism
Scientific Title:Acronym	Effect of a plant-derived processed food on dietary fat oxidation
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Fat oxidation measures after 1wk repeated ingestion
Key secondary outcomes

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	Ingestion of test diet (code name: A-004) for 1 weeks > wash out more than 1 weeks > Ingestion of control diet (code name: C-004) for 1 weeks. dose: one serving size per day Energy metabolism will be measured after 1wk repeated ingestion
Interventions/Control_2	Ingestion of control diet (code name: C-004) for 1 weeks > wash out more than 1 weeks > Ingestion of test diet (code name: A-004) for 1 weeks. dose: one serving size per day Energy metabolism will be measured after 1wk repeated ingestion
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, Aged between 35 and 64 2, BMI >= 23 and <30 kg/m2 3, Person who provides informed consent by a document
Key exclusion criteria	1, Hepatic, renal, or cardiac diseases, respiratory impairment, endcrinopathy, metabolic impairment, neuropathy, impaired mental status, diabetes, other disorders that would make participation in a study difficult 2, Surgery for disease or injury within 2 months before the study 3, Treatment with medication to improve glucose metabolism, fat metabolism, or blood pressure 4, Regular consumption Food with Health Claims (Food for Specified Health Uses [FOSHU], Foods with functional Claims, and nutritional food supplements) and supplements 5, Individual experienced unpleasant feeling during blood drawing. 6, Donation of 200mL or more of blood within 1month before the study 7, Heavy smoker (21 cigarettes a day or more) 8, Inability to continuous administration in the test diets 9, Potential to exhibit allergic symptoms to the ingredients in the test diets 10, Shift-worker 11, Intention to live or travel overseas for an extended period (6 or more consecutive days) during the study period (including wash-out periods) 12, Inability to record a diet for 9 days (3 days x 3 times) 13, Lock of consent to view previous medical records 14, Current participation in another clinical study or who intended to participate in one during the study period 15, Person who are considered inappropriate by medical doctors.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahiro Ono
Organization	MEDICS Hongo Clinic
Division name	Director
Zip code
Address	2-2-6 Mukogaoka, Bunkyo-ku, Tokyo
TEL	03-6801-9761
Email	info@tes-h.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ryoma Shimizu
Organization	TES Holdings Co. Ltd
Division name	Administrative Department of Clinical Trials
Zip code
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	MEDICS Hongo Clinic
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 19 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	Completed
Date of protocol fixation	2016 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date	2016 Year 05 Month 19 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	2016 Year 05 Month 19 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025250