UMIN-CTR Clinical Trial

Basic information
Public title	Suppressive effect of test food on the postprandial triglyceride level. -A randomized, double blind, placebo controlled, cross-over study-
Acronym	Suppressive effect of test food on the postprandial triglyceride level.
Scientific Title	Suppressive effect of test food on the postprandial triglyceride level. -A randomized, double blind, placebo controlled, cross-over study-
Scientific Title:Acronym	Suppressive effect of test food on the postprandial triglyceride level.
Region	Japan

Condition
Condition	Adult men and women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food on the postprandial triglyceride level of subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Area under the curve for postprandial serum triglyceride leve.
Key secondary outcomes	Area under the curve for Remnant-like particle cholesterol, and serum triglyceride levels and Remnant-like particle cholesterol of before, 2, 3, 4 and 6 hours after high fat meal ingestion.

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	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food (single ingestion) - washout period - intake of placebo (single ingestion).
Interventions/Control_2	Intake of placebo (single ingestion) - washout period - intake of test food (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)Males and females from 20 to 64 years of age. 2)Subjects whose fasting serum triglyceride levels is less than 200 mg/dL. 3)Subjects who are available to the scheduled visits including overnight stay in the hospital. 4)Subjects who agree to participate in the study and who can sign, seal and date the consent forms by themselves.
Key exclusion criteria	1)Subjects who have serious medical history or who had digestive tract resectional surgery (except for appendectomy). 2)Subjects who routinely use medicine, supplements, FOSHU and/or health food which may affect the result of the study. 3)Subjects who have allergy to the test food or high fat meal and have extreme lactose intolerance or diarrhea. 4)Subjects who are planning to become pregnant during the study or are pregnant or lactating. 5)Heavy user of alcohol or heavy smokers. 6)Subjects who are judged as inappropriate to participate in the study by the investigator for other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Ishikawa
Organization	Medical Corporation Shoureikan Sinsapporo seiryou Hospital
Division name	internal medicine
Zip code	004-0004
Address	2-1-30, Atsubetsuhigashi4jo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	080-6082-7362
Email	kanamori@hpgr.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Takehara
Organization	Clinical Support Corporation Limited
Division name	Food Service Division
Zip code	060-0061
Address	4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061 Japan
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical corporation Hokubukai beauty hill hospital ethics review committee
Address	No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido
Tel	011-882-0111
Email	wakimoto@ughp-cpc.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	医療法人社団翔嶺館新札幌聖陵ホスピタル（北海道）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 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	2018 Year 12 Month 13 Day
Date of IRB	2019 Year 01 Month 10 Day
Anticipated trial start date	2019 Year 03 Month 02 Day
Last follow-up date	2019 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 22 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040547