UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032218 |
|---|---|
| Receipt number | R000036734 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2021/02/17 10:47:43 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Postprandial Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing 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 comfirm the effect of food containing plant extract on postprandial serum triglyceride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum triglyceride AUC
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
Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Interventions/Control_2
Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single ingestion.
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
| 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.
Key exclusion criteria
(1) Subjects who use oral medications affecting lipid metabolism.
(2) Subjects who 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.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who have declared allergic reaction to ingredients contained in test foods or high-fat diets.
(5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(6) Subjects who have a chronic disease and use medications continuously.
(7) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(8) Subjects who are judged as unsuitable for the current study based on the results of screening tests by the investigator.
(9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(10) Subjects who are prone to diarrhea.
(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 have been diagnosed as familial hyperlipidemia.
(13) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(14) Subjects who are planning to participate and/or have participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Shinagawa Season Terrace Health Care Clinic
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
Tel
03-3452-3382
tomohiro_kogo@sempos.or.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036734
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/47060/949
Number of participants that the trial has enrolled
90
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2020 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 20 to 64 years old.
Participant flow
Enrolled(n=90)
Completed(n=89)
Analysed(n=76)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Serum triglyceride AUC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036734
