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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017824
Receipt No. R000020645
Scientific Title A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial
Date of disclosure of the study information 2015/06/05
Last modified on 2016/02/18

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Basic information
Public title A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial
Acronym A study for evaluating the effect of the intake of indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride
Scientific Title A study for evaluating the effect of the intake of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride : randomized, placebo-controlled, double blind cross-over trial
Scientific Title:Acronym A study for evaluating the effect of the intake of indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of an indigestible dextrin-containing beverage on postprandial increase in Serum Triglyceride
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes area under the curve for serum triglyceride levels
Key secondary outcomes fasting triglyceride level, triglyceride level of 2,3,4 and 6hours after the high-fat meal ingestion, Remnant-like particle cholesterol

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
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 test beverage containing of indigestible dextrin
Interventions/Control_2 placebo beverage without indigestible dextrin
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) Males and females from 20 to 64 years of age
(2) fasting triglyceride levels
are ranged from 120 mg/dL to 199 mg/dL

Key exclusion criteria (1) Subjects who routinely use food containing of indigestible dextrin
(2) Subjects routinely taking medicine or health food which may influence lipid metabolism
(3) Subjects who are under medication or having a history of serious diseases for which medication was required
(4) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(8) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1) Sumio Kondo, 2)Kumie Ito
Organization 1)Medical Corporation Kensho-kai,Fukushima Healthcare Center
2)Yaesu Sakuradori Clinic
Division name 1)Internal Medicine, Department of Neurosurgery 2)Internal Medicine
Zip code
Address 1) 2-12-16 tamagawa,fukushima-ku,osaka-shi,Osaka,553-0004,Japan 2)1-6-6yaesu,chuo-ku,Tokyo,Japan
TEL 06-6441-6848.03-6214-1285
Email ko283434@ares.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiharu Goto
Organization TTC Co.,Ltd
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email c.goto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization Coca Cola (Japan) 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
Address
Tel
Email

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 06 Month 05 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
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
2015 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Principal investigator's E-mail adress 2):info@y-sakuradoori.jp

Management information
Registered date
2015 Year 06 Month 05 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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