UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym	A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
Scientific Title	A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To comfirm the effect of food containing plant extract on postprandial serum triglyceride
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum triglyceride AUC
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	Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Interventions/Control_2	Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose fasting serum triglyceride levels are under 150 mg/dL. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who use oral medications affecting lipid metabolism. (2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting lipid metabolism during test periods. (3) Subjects who can't stop drinking from 2 days before each measurement. (4) Subjects who have declared allergic reaction to ingredients contained in test foods or high-fat diets. (5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (6) Subjects who have a chronic disease and use medications continuously. (7) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (8) Subjects who are judged as unsuitable for the current study based on the results of screening tests by the investigator. (9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (10) Subjects who are prone to diarrhea. (11) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (12) Subjects who have been diagnosed as familial hyperlipidemia. (13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (14) Subjects who are planning to participate and/or have participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
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	Ethical Committee of Shinagawa Season Terrace Health Care Clinic
Address	1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
Tel	03-3452-3382
Email	tomohiro_kogo@sempos.or.jp

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	2018 Year 04 Month 13 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036734
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/47060/949
Number of participants that the trial has enrolled	90
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2020 Year 04 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 20 to 64 years old.
Participant flow	Enrolled(n=90) Completed(n=89) Analysed(n=76)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	Serum triglyceride AUC
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 04 Month 04 Day
Date of IRB	2018 Year 04 Month 04 Day
Anticipated trial start date	2018 Year 04 Month 14 Day
Last follow-up date	2018 Year 07 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036734