UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027893 |
|---|---|
| Receipt number | R000031960 |
| Scientific Title | Suppressive effect of test food on postprandial serum triglyceride level |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2018/12/25 09:40:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Suppressive effect of test food on postprandial serum triglyceride level
Acronym
Suppressive effect of test food on postprandial serum triglyceride level
Scientific Title
Suppressive effect of test food on postprandial serum triglyceride level
Scientific Title:Acronym
Suppressive effect of test food on postprandial serum triglyceride level
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the suppressive effect of test food on elevation of postprandial serum triglyceride
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of delta AUC (area under the curve) and delta serum triglyceride level
Key secondary outcomes
Time course of AUC (area under the curve) and serum triglyceride level
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
The capsule containing kiwi fruit extract intake - Washout - Placebo intake
Interventions/Control_2
Placebo intake - Washout - The capsule containing kiwi fruit extract intake
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy subjects aged 20 to 59 years old
(2) BMI < 25
(3) Subjects whose fasting serum triglyceride level is <= 150 mg/dL
(4) Subjects who agree to participate in the current study with written informed consent
Key exclusion criteria
(1) Subjects who use oral medication, supplements and/or functional foods affecting lipid metabolism
(2) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(3) Subjects who are suffered from or under treatment of serious disease (e.g., heart disease, liver disease, kidney disease, and/or digestive disease)
(4) Subjects who are under treatment of alcohol dependence
(5) Subjects who are extremely irregular in eating habits
(6) Subjects who declare the allergy symptoms against drugs and/or foods
(7) Subjects who are participating in other clinical trials of drugs or health food, who participated in the last 4 weeks, or who are willing to participate after giving the informed consent
(8) Subjects who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study
(9) Males who have donated over 400 mL of blood and/or blood component within the last three months prior to the current study
(10) Females who have donated over 400 mL of blood and/or blood component within the last four months prior to the current study
(11) Males whose total blood collection volume exceeding 1200 mL within the last twelve months prior to the current study (include the blood collection volume of the current study)
(12) Females whose total blood collection volume exceeding 800 mL within the last twelve months prior to the current study (include the blood collection volume of the current study)
(13) Subjects who are predicted to be difficult to comply with agreements and subject management
(14) Subjects who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Maruyama |
Organization
Omnica Co.,Ltd.
Division name
Research and Development Dept.
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
t.maruyama@omnica.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Iwata |
Organization
Omnica Co.,Ltd.
Division name
Research and Development Dept.
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9815
Homepage URL
iwata@omnica.co.jp
Sponsor or person
Institute
CPCC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Omnica 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
チヨダパラメディカルケアクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031960
