UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018978 |
|---|---|
| Receipt number | R000020498 |
| Scientific Title | Study on effects of a plant derived processed product on postprandial triglyceride |
| Date of disclosure of the study information | 2015/09/11 |
| Last modified on | 2019/07/26 11:10:50 |
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Basic information
Public title
Study on effects of a plant derived processed product on postprandial triglyceride
Acronym
Study on effects of a plant derived processed product on postprandial triglyceride
Scientific Title
Study on effects of a plant derived processed product on postprandial triglyceride
Scientific Title:Acronym
Study on effects of a plant derived processed product on postprandial triglyceride
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of a food product on postprandial triglyceride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial triglyceride
(blood collection : fasting and 2,3,4,6 hours after the test meal)
Key secondary outcomes
apo-B48
physical examination
blood general analysis
biochemical test
urinalysis
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
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
placebo food (code name;C-001)
single ingestion
group 1
placebo food - test food 1 - test food 2
Interventions/Control_2
placebo food (code name;C-001)
single ingestion
group 2
placebo food - test food 2 - test food 1
Interventions/Control_3
test food 1 (code name;A-001)
single ingestion
group 3
test food 1 - placebo food - test food 2
Interventions/Control_4
test food 1 (code name;A-001)
single ingestion
group 4
test food 1 - test food 2 - placebo food
Interventions/Control_5
test food 2 (code name;A-002)
single ingestion
group 5
test food 2 - placebo food - test food 1
Interventions/Control_6
test food 2 (code name;A-002)
single ingestion
group 5
test food 2 - test food 1 - placebo food
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Fasting triglyceride >=120, and < 200mg/dL
2, Aged between 35 and 64
3, BMI >= 23 and <30 kg/m2
4, Person who provides informed consent by a document
Key exclusion criteria
1, Person who is difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions.
2, Person who takes medication for glucose or fat metabolism, or hypertension.
3, Person who was given surgery for a disease or an injury 2 months prior to the study.
4, Individual intakes supplements or the food for specific use of health authorized the government.
5, Person had allergy against any constituents in the test diet.
6, Person who is used to take test food.
7, Individual experienced unpleasant feeling during blood drawing.
8, Person who donated 200mL or more of blood within a month prior to the study.
9, Heavy smoker
10, Person who don't record of meal recoding for 9 days
11, Shift worker
12, Person who is planned long term business trip or travel of a domestic or foreign country in study period
13, Person who can't accept to be accessed their medical records.
14, Person who have participated in other clinical studies.
15, Person who are expecting pregnancy or lactation period.
16, Person who are considered inappropriate by medical doctors.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Katuragi |
Organization
Kao corporation
Division name
Health Care Food Research Labs
Zip code
131-8501
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7452
katsuragi.yoshihisa@kao.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Ryoma |
Organization
TES Holdings Co. Ltd
Division name
Sales department for tissue engineering and clinical research
Zip code
113-0033
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-5449-5120
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co. Ltd
Institute
Department
Personal name
Funding Source
Organization
KAO CORPORATION
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
Oriental Ueno medical center
Address
1-20-11 Ueno Taito-ku Tokyo
Tel
03-5816-0711
info@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/28202845
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28202845
Number of participants that the trial has enrolled
48
Results
There was a significant difference in the primary outcome
Results date posted
| 2019 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
men and women between 35 and 64 year of age.
fasting blood TG levels of 120 to 199 mg/dL
Participant flow
46 participants completed and 38 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets
Outcome measures
postprandial TG level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 11 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020498
