UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppressive effect of test food on postprandial serum triglyceride level
Title of the study (Brief title)	Suppressive effect of test food on postprandial serum triglyceride level
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the suppressive effect of test food on elevation of postprandial serum triglyceride
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of delta AUC (area under the curve) and delta serum triglyceride level
Key secondary outcomes	Time course of AUC (area under the curve) and serum triglyceride level

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	The capsule containing kiwi fruit extract intake - Washout - Placebo intake
Interventions/Control_2	Placebo intake - Washout - The capsule containing kiwi fruit extract intake
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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy subjects aged 20 to 59 years old (2) BMI < 25 (3) Subjects whose fasting serum triglyceride level is <= 150 mg/dL (4) Subjects who agree to participate in the current study with written informed consent
Key exclusion criteria	(1) Subjects who use oral medication, supplements and/or functional foods affecting lipid metabolism (2) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period (3) Subjects who are suffered from or under treatment of serious disease (e.g., heart disease, liver disease, kidney disease, and/or digestive disease) (4) Subjects who are under treatment of alcohol dependence (5) Subjects who are extremely irregular in eating habits (6) Subjects who declare the allergy symptoms against drugs and/or foods (7) Subjects who are participating in other clinical trials of drugs or health food, who participated in the last 4 weeks, or who are willing to participate after giving the informed consent (8) Subjects who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study (9) Males who have donated over 400 mL of blood and/or blood component within the last three months prior to the current study (10) Females who have donated over 400 mL of blood and/or blood component within the last four months prior to the current study (11) Males whose total blood collection volume exceeding 1200 mL within the last twelve months prior to the current study (include the blood collection volume of the current study) (12) Females whose total blood collection volume exceeding 800 mL within the last twelve months prior to the current study (include the blood collection volume of the current study) (13) Subjects who are predicted to be difficult to comply with agreements and subject management (14) Subjects who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuya Maruyama
Organization	Omnica Co.,Ltd.
Division name	Research and Development Dept.
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Email	t.maruyama@omnica.co.jp

Public contact
Name of contact person	Satomi Iwata
Organization	Omnica Co.,Ltd.
Division name	Research and Development Dept.
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Homepage URL
Email	iwata@omnica.co.jp

Sponsor
Institute	CPCC Co.,Ltd.
Institute
Department

Funding Source
Organization	Omnica Co.,Ltd.
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	チヨダパラメディカルケアクリニック(東京都)

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 22 Day
Anticipated trial start date	2017 Year 06 Month 26 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	2017 Year 06 Month 23 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031960