UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014313 |
|---|---|
| Receipt number | R000016545 |
| Scientific Title | Effects of a repeated consumption of a fat and oil product for 3 months in hypertriglyceridemia |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2019/08/20 13:52:38 |
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Basic information
Public title
Effects of a repeated consumption of a fat and oil product for 3 months in hypertriglyceridemia
Acronym
Study on 3-month consumption of a fat and oil product
Scientific Title
Effects of a repeated consumption of a fat and oil product for 3 months in hypertriglyceridemia
Scientific Title:Acronym
Study on 3-month consumption of a fat and oil product
Region
| Japan |
Condition
Condition
hypertriglyceridemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of repeated consumption of a fat and oil pruduct for 3 months in hypertriglyceridemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fasting serum TG conc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
placebo control 1 serving for 12wk
Interventions/Control_2
fat and oil product, dose 1 1 serving for 12wk
Interventions/Control_3
fat and oil product, dose 2 1 serving for 12wk
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. People with fasting serum TG conc. between 120 and 329 mg/dL
2. People with fasting serum conc. 5 and under (desirable) or 4 and under (more desirable)
3. men and women aged between 35 and 64
4. people who can accept to be accessed their medical records and agree with the study protocol followed by a prior explanation
5. people who provide informed concent by a document
Key exclusion criteria
1. People who are 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. People who were given surgery for a disease or an injury
3. People who take medication for glucose or fat metabolism, or hypertension
4. People who habitually consume the foods for specific health use (FOSHU) and/or dietary supplements (capsules) (except for
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Saito |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
362-0051
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7456
saito.shinichiro@kao.co.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Shibakiri |
Organization
Qol RD Co., Ltd
Division name
FoodCRO Division
Zip code
103-0027
Address
2-14-1 Nihonbashi Chuo-ku Tokyo
TEL
03-6386-8809
Homepage URL
c-shibakiri@qol-rd.co.jp
Sponsor or person
Institute
Qol RD 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
Ugeo Kose Clinic IRB
Address
421-1, Zitoukata, Ugeo City
Tel
048-781-1101
soumu@ach2.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
上尾甦生病院、金沢文庫病院、東川口病院、白岡中央総合病院、関野臨床薬理クリニック、東京ハートセンター、金内メディカルクリニック、中島クリニック
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
90
Results
No significant difference in the primary outcome
Results date posted
| 2019 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hyperlipidemia
Participant flow
98 participants completed and 90 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
triglyceride
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016545
| Research Plan | |
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| Registered date | File name |
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