UMIN-CTR Clinical Trial

Basic information
Public title	The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study-
Acronym	The attenuating effect of HBF2019-03 on postprandial serum triglyceride level.
Scientific Title	The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study-
Scientific Title:Acronym	The attenuating effect of HBF2019-03 on postprandial serum triglyceride level.
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of HBF2019-03 on the suppression of the 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 serum triglyceride level and AUC (area under the curve) (0-6hrs)
Key secondary outcomes	*Secondary outcomes Time course of serum RLP-cholesterol level and AUC (area under the curve) (0-6hrs) *Safety Doctor's questions

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	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Placebo food (a single time intake) -> 1-week washout -> Test food, containing HBF2019-03 (a single time intake)
Interventions/Control_2	Test food, containing HBF2019-03 (a single time intake) -> 1-week washout -> Placebo food (a single time 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1] Healthy males and females aged 20-64 years old when informed consent. [2] Fasting serum triglyceride level is between 120 and 200 mg/dL. [3] Who don't large amount of alcohol habitually. [4] Who are judged not suffering from a disease by the investigator. [5] Individuals giving written informed consent.
Key exclusion criteria	[1] Who use medical products affecting lipid metabolism. [2] Who can't stop using supplements which affecting lipid metabolism during the study period. [3] Who can't abstinent from alcohol from two days before each examination. [4] Who are allergic to placebo food and/or test food and/or the ingredient of high-fat meal. [5] Who have a history of serious kidney damage, hepatopathy, heart disease, respiratory disease, endocrine disease, or any other metabolic disease(s) or who is under medical treatment. [6] Who have chronic disease and is under medication. [7] Who have digestive organ disease or surgical history affecting digestion and absorption of foods. [8] Who are judged inappropriate for the study by the investigator in the screening. [9] Who are diagnosed as severe anemia in screening and not suitable for frequent collection of blood. [10] Who had an onset diarrhea within a week from the date of screening, and/or who are prone to diarrhea on a daily basis. [11] Who with significantly different fasting serum triglycerides levels of each test day. [12] Who have little change in serum triglyceride level after intake high-fat meal, or who continue to rise 6 hours after the meal, or who are judged abnormal changes in serum triglyceride level by the investigator in the screening. [13] Who donated blood over 200mL in the past a month or over 400mL in the past 3 months from the date of informed consent. [14] Who are diagnosed as familial hyperlipidemia. [15] Who are drug addict and/or alcohol addict. [16] Who with irregular life rhythms such as shift workers or works late at night. [17] Who are participating in other studies that using food(s), pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent. [18] Who are or are possibly pregnant, or who are lactating, during the study period. [19] Who are judged inappropriate for the study by the investigator.
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	Kyodo Bldg. #201, 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	Shibaura-omodaka Bldg. 7F, 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	Hayashibara 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 Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.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	医療法人財団健康睡眠会　日本橋循環器科クリニック（東京都） /Nihonbashi Cardiology Clinic（Tokyo）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 21 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	90
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	2019 Year 09 Month 10 Day
Date of IRB	2019 Year 09 Month 10 Day
Anticipated trial start date	2019 Year 09 Month 21 Day
Last follow-up date	2019 Year 11 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 09 Month 18 Day
Last modified on	2020 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043364