UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for an effect of the food containing plant-derived ingredient on serum fat.
Title of the study (Brief title)	Effect of plant-derived ingredient on serum fat.
Region	Japan

Condition
Condition	Nothing (Healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of the plant-derived ingredient on post prandial serum fat.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post prandial serum fat
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	Prevention
Type of intervention	Food
Interventions/Control_1	Single intake of active food (product code: Q-001) > wash out more than 5 days > Single intake of placebo food (product code: P-001)
Interventions/Control_2	Single intake of placebo food (product code: P-001) > wash out more than 5 days > Single intake of active food (product code: Q-001)
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	30 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Age>=30 and <60 years 2.BMI>=18.5 and < 30 kg/m2
Key exclusion criteria	1.Person who is presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases. 2.Person who has surgery within 2 months before the trial. 3.Person who taking medications for hyperglycaemia, lipid metabolism, or hypertension. 4.Person who taking supplements or foods that affect this trial. 5.Person who experienced unpleasant feeling during drawing blood. 6.Person who has donated over 200 mL blood within one month. 7.Person whose serum TG is over 200 mg/dL. 8.Person who is heavy smoker 9.Person who has food allergies. 10.Person who is shift worker. 11.Person who plans business trip lasting 5 consecutive days or more. 12.Person who participating or planning to participating in other clinical trial. 13.Person who can't agree informed consent. 14.Person who is pregnant or lactating 15.Person who is judged to be inappropriate for this study by the supervising physician or principal investigator for other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Takahiro Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	t.ono@ueno-asagao.clinic

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
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	うえのあさがおクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 10 Month 24 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	2018 Year 10 Month 11 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039286