UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014313
Receipt No. 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 (Ver. 14)

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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
Email 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
Email c-shibakiri@qol-rd.co.jp

Sponsor
Institute Qol RD Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016545