UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Test Food on Postprandial Serum Triglyceride level
Acronym	A Study on the Effect of Test Food on Postprandial Serum Triglyceride level
Scientific Title	A Study on the Effect of Test Food on Postprandial Serum Triglyceride level
Scientific Title:Acronym	A Study on the Effect of Test Food on Postprandial Serum Triglyceride level
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of test food 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	A test food "A" with high fat diet
Interventions/Control_2	A placebo food with high fat diet
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who can understand the trial, make self-judgment and are voluntarily giving written informed consent. 2. Subjects whose fasting serum triglyceride levels are below 150 mg/dL. 3. Subjects who can be considered appropriate for the participation on this exam by study physician.
Key exclusion criteria	1. Subjects who have a chronic disease and use medicines continuously. 2. Subjects who use oral medication past one month to treat disease (exclude for headache, menstrual pain, common cold) 3. Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, and/or heart disease, vascular disease). 4. Subjects who have a history of digestive disease affecting digestion and absorption (exclude for acute appendicitis history). 5. Subjects with high level of anemia 6. Subjects who have declared allergic reaction to ingredients contained in test products. 7. Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. 8. Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 9. Subjects who have the possibility to change lifestyle habits during the trial (night work, overseas business trips etc) 10. Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting lipid metabolism in study period. 11. 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. 12. Subjects who currently participating in other human clinical trials or have not passed for 3 months after joining the other human clinical trials 13. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	12

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masayasu Ban
Organization	Mizkan Holdings Co., Ltd.
Division name	Central Research Institute
Zip code
Address	2-6 Nakamuracho, Handa, Aichi
TEL	0569-24-5139
Email	mban@mizkan.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Atsushi Ishikawa
Organization	Mizkan Holdings Co., Ltd.
Division name	Central Research Institute
Zip code
Address	2-6 Nakamuracho, Handa, Aichi
TEL	0569-24-5139
Homepage URL
Email	aishikawa@mizkan.co.jp

Sponsor
Institute	Mizkan Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Mizkan Holdings 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
Address
Tel
Email

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 11 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	11
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 10 Month 23 Day
Date of IRB	2018 Year 10 Month 24 Day
Anticipated trial start date	2018 Year 11 Month 21 Day
Last follow-up date	2018 Year 12 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 02 Month 04 Day

Other
Other related information

Management information
Registered date	2018 Year 11 Month 19 Day
Last modified on	2019 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039803