UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033586 |
|---|---|
| Receipt number | R000038301 |
| Scientific Title | A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX) |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2019/08/15 07:40:22 |
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Basic information
Public title
A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Acronym
An RCT (randomized controlled trial) on lipid metabolic effect of a food ingredient (G-PX)
Scientific Title
A randomized placebo-controlled double-blind parallel-group trial on lipid metabolic effect of a food ingredient (G-PX)
Scientific Title:Acronym
An RCT (randomized controlled trial) on lipid metabolic effect of a food ingredient (G-PX)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the trial is to evaluate variation of lipid-related factors in blood after food intake in healthy Japanese men and women with no disease aged 20 years or older.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the amount of L/H ratio changes with placebo as a control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
carotenoid
Interventions/Control_2
placebo
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Persons with relatively high oxidized LDL/LDL cholesterol
(2) Persons with relatively high LDL cholesterol/HDL cholesterol (LH ratio)
(3) Persons with BMI 30 or lower
(4) Persons who can visit designated facilities on scheduled visiting dates
(5) Persons who fully understood the purpose and content of the trial and gave written consent
Key exclusion criteria
(1) Persons who are receiving any treatment at the time of participation in the trial
(2) Pregnant women (including those who are potentially pregnant) or lactating women
(3) Smokers
(4) Persons who made a blood component donation or whole blood donation of 200 mL within 4 weeks prior to the trial food intake
(5) Persons who made a whole blood donation of 400 mL within 16 weeks prior to the trial food intake
(6) Persons who underwent blood drawing of over 1000 mL within 48 weeks prior to the trial food intake
(7) Persons who are participating in other trials or studies
(8) Persons who meet any of the following:
1) Persons with heart, liver or kidney diseases (including complications of other diseases)
2) Persons with medical history of circulatory diseases
3) Persons with diabetes mellitus
4) Persons currently receiving treatment for or with medical history of serious diseases such as cancer or asthma
(9) Persons with history of major surgery in the site of gastrointestinal tract such as gastrectomy, gastroenterostomy, or intestinal resection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kuriki |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of Health Sciences
Zip code
5558502
Address
4-6-5 Utajima, Nishiyodogawa, Osaka 555-8502, JAPAN
TEL
06-6477-8425
takashi.kuriki@glico.com
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Nakano |
Organization
edihas Co., Ltd.
Division name
Division of Clinical Trial Support
Zip code
0600041
Address
2-3-1, Ohodouri-higashi, Chuoo-ku, Sapporo-city, Hokkaido, Japan
TEL
0112527419
Homepage URL
nakano@edihas.co.jp
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Graduate School of Agricultural Science / Faculty of Agriculyure
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Utsukushigaoka
Address
Sapporo-city, kiyota-ku, 61-1
Tel
011-882-0111
matsuda@ughp-cpc.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
医療法人波津診療所
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
60
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
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 25 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038301
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
