UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a Functional Food for Postprandial Triglyceride.
Acronym	Effect of a Functional Food for Postprandial Triglyceride.
Scientific Title	Effect of a Functional Food for Postprandial Triglyceride.
Scientific Title:Acronym	Effect of a Functional Food for Postprandial Triglyceride.
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effect of a functional food for postprandial triglyceride.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Efficacy evaluation (changes, increase and decrease, Cmax, delta Cmaxm AUC and iAUC of TG and NEFA(1); blood viscosity and lipid composition analysis(2)). (1): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet). (2): Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
Key secondary outcomes	*Safety [1]Blood pressure, pulsation(1). [2]Weight, body fat percentage, BMI(2). [3]Doctor's questions(1). [4]Subject's diary(3). *Other indexes [1]Hematologic test(4). [2]Blood biochemical test(2). [3]Urine analysis(4). [4]Anti-Aging QOL Common Questionnaire(2). (1):Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet). (2):Screening; Week 0, Week 4 (before ingestion of a challenge diet). (3):From two days before ingestion of a challenge diet in observation period I to one day before ingestion of a challengediet in Week 4. (4):Screening. (5): Week 0, Week 4 (before ingestion of a challenge diet).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	[1]Oral Fat Tolerance Test (1 time). [2]Oral intake of the tes food (6 tablets in a day; 4 weeks). [3]Oral Fat Tolerance Test (1 time).
Interventions/Control_2
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]Japanese males and females aged 20-64 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals whose triglyceride level is high-normal (120-149 mg/dL) or who are mild hyperlipemia (150-199mg/dL). [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions. [3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease. [5]Individuals who have digestive organ disease (disease of an appendix is removed). [6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females). [7]Individuals whose BMI is over 30kg/m2. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals with serious anemia. [10]Individuals who are difficult to conduct blood collections over time. [11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies. [12]Individuals who cannot intake every diet the day before the inspection day or every loading food. [13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day. [14]Individuals whose life style will change during the test period (ex. travel for a long time). [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period. [16]Individuals who are or are possibly pregnant, or are lactating. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individuals judged inappropriate for the study by the principal.
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Kondo
Organization	Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name	Head
Zip code	169-0072
Address	3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL	+81-3-6233-8583
Email	h.kondo@meiseikai-cl.com

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	KOBAYASHI Pharmaceutical 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@tes-h.co.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	2020 Year 11 Month 06 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	2020 Year 10 Month 23 Day
Date of IRB	2020 Year 10 Month 26 Day
Anticipated trial start date	2020 Year 11 Month 18 Day
Last follow-up date	2020 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 05 Day
Last modified on	2021 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048321