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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032218
Receipt No. R000036734
Scientific Title A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Date of disclosure of the study information 2018/04/13
Last modified on 2018/04/12

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Basic information
Public title A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
Scientific Title A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
Region
Japan

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

Objectives
Narrative objectives1 To comfirm the effect of food containing plant extract on postprandial serum triglyceride
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum triglyceride AUC
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 Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Interventions/Control_2 Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, 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) Healthy males and females aged 20 to 64 years-old.
(2) Subjects whose fasting serum triglyceride levels are under 150 mg/dL.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who use oral medications affecting lipid metabolism.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting lipid metabolism during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who have declared allergic reaction to ingredients contained in test foods or high-fat diets.
(5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(6) Subjects who have a chronic disease and use medications continuously.
(7) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(8) Subjects who are judged as unsuitable for the current study based on the results of screening tests by the investigator.
(9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(10) Subjects who are prone to diarrhea.
(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 have been diagnosed as familial hyperlipidemia.
(13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(14) Subjects who are planning to participate and/or have participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 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 TOYO SHINYAKU 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 04 Month 13 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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