UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a Food to Suppress the Increase in Postprandial Triglyceride Levels
Title of the study (Brief title)	Effect of a Food to Suppress the Increase in Postprandial Triglyceride Levels
Region	Japan

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

Objectives
Narrative objectives1	This study aims to examine effect of a food to suppress the increase in postprandial triglyceride level.
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 of TG, NEFA, lipoprotein fraction, RLP-C [before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet; AUC and iAUC of TG, NEFA, lipoprotein fraction, RLP-C [observation period I and II]).
Key secondary outcomes	*Indexes for safety [1]Blood pressure, pulsation (screening and before ingestion of a challenge diet). [2]Weight, body fat percentage, BMI (screening and before ingestion of a challenge diet) . [3]Doctor's questions (screening, before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet). [4]Subject's diary (from one day before ingestion of a challenge diet in observation period I to one day before ingestion of a challenge diet in observation period II) *Other indexes [1]Hematologic test (screening) [2]Blood biochemical test (screening) [3]Urine analysis (screening)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	[1]Oral ingestion of a test food (1 time). [2]Oral ingestion of a challenge diet. [3]Observation. [4]Washout (over 6 days) [5]No ingestion of a test food. [6]Oral ingestion of a challenge diet. [7]Observation.
Interventions/Control_2	[1]No ingestion of a test food. [2]Oral ingestion of a challenge diet. [3]Observation. [4]Washout (over 6 days) [5]Oral ingestion of a test food (1 time). [6]Oral ingestion of a challenge diet. [7]Observation.
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 20-65 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals whose triglyceride level is normal or who are mild hyperlipemia (120mg/dL-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 sensitive to test products or causes severe allergy in a food and medical supplies. [11]Individuals who cannot intake every loading food or test food. [12]Individuals who are or are possibly pregnant, or are lactating. [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). [15Individuals 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 participated in other clinical studies in the past 3 months. [17]Individuals judged inappropriate for the study by the principal.
Target sample size	40

Research contact person
Name of lead principal investigator	Ryuzo Hanada
Organization	Medical Corporation SOUSEIKAI Sumida Hospital
Division name	Internal Medicine
Address	Random Square Honjo, 1-29-1 Honjo Sumida-ku Tokyo, 130-0004 JAPAN
TEL	03-5608-7276
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, 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	Riken Vitamin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 25 Day
Anticipated trial start date	2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 15 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037577