UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034935
Receipt number R000039834
Scientific Title A Study on the Effect of Test Food on Postprandial Serum Triglyceride level
Date of disclosure of the study information 2018/11/21
Last modified on 2019/05/20 10:35:03

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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 "B" 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

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

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 or person

Institute

Mizkan Holdings Co., Ltd.

Institute

Department

Personal name



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

12

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 15 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039834


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name