UMIN-CTR Clinical Trial

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

Condition
Condition	No (Subjects with high fasting serum triglyceride)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Postprandial Serum Triglyceride
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 polydextrose, 1 per serving
Interventions/Control_2	Food not containing polydextrose, 1 per serving
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 from 120 mg/dL to 199 mg/dL. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1)Subjects who use oral medication affecting lipid metabolism. (2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting lipid metabolism. (3)Subjects who can't stop drinking for 2 days before the screening checkup or each measurement. (4)Subjects who have declared allergic reaction to ingredients contained in high-fat diets. (5)Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (6)Subjects who have a chronic disease and use medicines continuously. (7)Subjects who have a history of digestive disease affecting digestion and absorption. (8)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator. (9)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. (10)Subjects who are diagnosed as familial hyperlipidemia. (11)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (12)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (13)Subjects who are planning to participate in other clinical studies. (14)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (15)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Haruhi Middle name Last name Sugimura
Organization	C'est la vie Shimbashi Clinic
Division name	Medical office
Zip code	105-0003
Address	2-39-3 Nishishimbashi, Minato-ku, Tokyo
TEL	03-5408-8181
Email	h-sugimura@shinkokai.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 C'est la vie Shimbashi
Address	2-39-3 Nishishimbashi,Minato-ku, Tokyo
Tel	03-5408-8671
Email	m-fujii@shinkokai.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	2014 Year 07 Month 15 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000016875
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/43080/1149
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=90) Analysed(n=77)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	Postprandial Serum Triglyceride
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 07 Month 08 Day
Date of IRB	2014 Year 07 Month 15 Day
Anticipated trial start date	2014 Year 07 Month 16 Day
Last follow-up date	2014 Year 09 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Jpn Pharmacol Ther 2015 43(8)1149-56

Management information
Registered date	2014 Year 07 Month 11 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=R000016875