UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049506 |
|---|---|
| Receipt number | R000056376 |
| Scientific Title | Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, 3-way, 3-period, cross-over study- |
| Date of disclosure of the study information | 2022/11/16 |
| Last modified on | 2023/05/17 09:07:15 |
* 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 the postprandial triglyceride level
Acronym
Suppressive effect of test food on the postprandial triglyceride level
Scientific Title
Suppressive effect of test food on the postprandial triglyceride level -A randomized, open-label, 3-way, 3-period, cross-over study-
Scientific Title:Acronym
Suppressive effect of test food on the postprandial triglyceride level
Region
| Japan |
Condition
Condition
Adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the dose-response effect of test food on the postprandial triglyceride level of subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum triglyceride level of Area under the curve (AUC) for actual measured values as well as amount of changed values after high fat meal ingestion.
Key secondary outcomes
Serum triglyceride levels for actual measured values as well as amount of changed values of before, 2, 3, 4 and 6 hours after high fat meal ingestion. The maximum serum concentration (Cmax) of triglyceride. The time to maximum serum concentration (Tmax) of triglyceride.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of water (control) - washout period - intake of test food 1 - washout period - intake of test food 2 (single ingestion).
Interventions/Control_2
Intake of test food 1- washout period - intake of test food 2- washout period - intake of water (control) (single ingestion).
Interventions/Control_3
Intake of test food 2- washout period - intake of test food 1- washout period - intake of water (control) (single ingestion).
Interventions/Control_4
Intake of water (control) - washout period - intake of test food 2 - washout period - intake of test food 1 (single ingestion).
Interventions/Control_5
Intake of test food 1 - washout period - intake of water (control) - washout period - intake of test food 2 (single ingestion).
Interventions/Control_6
Intake of test food 2 - washout period - intake of water (control) - washout period - intake of test food 1 (single ingestion).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females 18 to 64 years of age.
2) Subjects whose fasting serum triglyceride levels are less than 200 mg/dL.
Key exclusion criteria
1)Subjects who has serious medical history or who had digestive tract resection surgery.
2) Subjects who is taking medication which affect to lipid metabolism.
3) Subjects who can not stop taking medicine, supplements and/or health food which affect to lipid metabolism.
4)Subjects who have allergy to the test food or high fat meal and have extreme lactose intolerance or diarrhea.
5)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
6)Heavy use of alcohol or excessive smokers.
7)Subjects who can not get their blood sampled as scheduled.
8)Subjects who is considered to be inappropriate to attend the present study by principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tarumizu |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
Homepage URL
chie_0904@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of FANCL Corporation
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagaw
Tel
045-820-3657
akihide_nisihara@fancl.co.jp
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
株式会社ファンケル 総合研究所（神奈川県）/
FANCL Corporation Research Institute (Kanagawa prefecture)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 16 | 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
24
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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056376
