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
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
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
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
