UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054526 |
|---|---|
| Receipt number | R000062287 |
| Scientific Title | A Study on the Effect of Plant Extract on Postprandial Serum Triglyceride -A Randomized, Cross-over Study- |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/05/30 17:12:30 |
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Basic information
Public title
A Study on the Effect of Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Cross-over Study-
Acronym
A Study on the Effect of Plant Extract on Postprandial Serum Triglyceride
Scientific Title
A Study on the Effect of Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of 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 confirm the effect of different timing of intake of plant extract on postprandial triglyceride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum triglyceride AUC
Key secondary outcomes
Changes in Serum triglyceride
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of plant extract 2 hours before the loading meal
Washout
Single intake of plant extract 1 hour before the loading meal
Washout
Single intake of plant extract with the loading meal
Washout
Single intake of plant extract after the loading meal
Washout
No ingestion of plant extract
Interventions/Control_2
Single intake of plant extract 1 hour before the loading meal
Washout
Single intake of plant extract with the loading meal
Washout
Single intake of plant extract after the loading meal
Washout
No ingestion of plant extract
Washout
Single intake of plant extract 2 hours before the loading meal
Interventions/Control_3
Single intake of plant extract with the loading meal
Washout
Single intake of plant extract after the loading meal
Washout
No ingestion of plant extract
Washout
Single intake of plant extract 2 hours before the loading meal
Washout
Single intake of plant extract 1 hour before the loading meal
Interventions/Control_4
Single intake of plant extract after the loading meal
Washout
No ingestion of plant extract
Washout
Single intake of plant extract 2 hours before the loading meal
Washout
Single intake of plant extract 1 hour before the loading meal
Washout
Single intake of plant extract with the loading meal
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.
(4) Subjects who are able to comply with the instructions given by the study staff (e.g., how to consume the load food).
Key exclusion criteria
Subjects (who)
(1)contract diseases (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, peripheral vascular disorder, and/or serious metabolic disease).
(2)use oral medications affecting lipid metabolism.
(3)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.
(4)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(5)currently undergoing treatment for a condition that may affect study results
(6)have declared allergic reaction to ingredients contained in test foods or high-fat diets.
(7)are diagnosed as anemic by screening tests and not suitable for frequent collection of blood, or have difficulty in collecting the prescribed amount of blood in fingertip blood collection.
(8)are shiftworker and/or midnight-shift worker.
(9)are under treatment for or have a history of drug addiction and/or alcoholism.
(10)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week, or can't stop drinking from 3 days before each measurement.
(11)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)are pregnant or planning to become pregnant or breastfeed during the study period.
(13)are planning to participate and/or have participated in other clinical studies.
(14)are judged as unsuitable for the current study by the investigator for other reasons.
(15)have difficulty consuming the prescribed meal (dinner on the day before the test) and the load food (on the day of the test).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinnya |
| Middle name | |
| Last name | Oikawa |
Organization
Medical Corporation asociations Shokoukai Comfo-Garden Clinic
Division name
Chairman
Zip code
162-0054
Address
Kawada-Cho3-2, Shinjyuku-ku, Tokyo
TEL
03-5368-6980
comfo-rinshou@synaps.co.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Honpo |
Organization
Synapse planning Co.,Ltd.
Division name
Clinical Trials Division
Zip code
162-0054
Address
Kawada-Cho 7-5,Shinjyuku-ku, Tokyo
TEL
03-5604-9442
Homepage URL
https://synaps.co.jp/
info@synaps.co.jp
Sponsor or person
Institute
Synapse planning Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Curves Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOYO SHINYAKU Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukiji Futaba Clinic Ethics Review Committee.
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo
Tel
03-6226-5812
info@hikobae.net
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
| 2024 | Year | 05 | Month | 31 | 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
| 2024 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062287
