UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014115 |
|---|---|
| Receipt number | R000016431 |
| Scientific Title | Study of Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2015/07/23 09:15:05 |
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Basic information
Public title
Study of Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride
Acronym
Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride
Scientific Title
Study of Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride
Scientific Title:Acronym
Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride
Region
| Japan |
Condition
Condition
No (subjects with high postprandial serum triglyceride)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of food containing resistant maltodextrin on postprandial serum triglyceride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial Serum Triglyceride
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing resistant maltodextrin, 1 food
Interventions/Control_2
Food not containing resistant maltodextrin, 1 food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)(Healthy) subjects aged 20 to 64 years old.
(2)Subjects whose fasting serum triglyceride levels are from 120 mg/dL to 200 mg/dL.
(3)Subjects giving written informed consent.
Key exclusion criteria
(1)Subjects who use oral medication affecting lipid metabolism.
(2)Subjects who constantly use supplements and/or functional foods affecting lipid metabolism.
(3)Subjects with excessive alcohol-drinking behaviors.
(4)Subjects who can't stop drinking for 2 days until the screening checkup
(5)Subjects who declare the allergy symptoms against high-fat diets.
(6)Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(7)Subjects who have a chronic disease and use medicines continuously.
(8)Subjects who have a history of digestive disease affecting digestion and absorption.
(9)Subjects who are judged as unsuitable for the study based on the results of blood test.
(10)Subjects who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(11)Subjects who is diagnosed as familial hyperlipidemia.
(12)Subjects who is diagnosed as severe anemia and not suitable for frequent collection of blood.
(13)Subjects who have under treatment or a history of drug addiction and/or alcoholism.
(14)Subjects who are planned to participate in other clinical study.
(15)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(16)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhi Sugimura |
Organization
C'est la vie Shinbashi Clinic
Division name
Medical office
Zip code
Address
2-39-3 Nishishinbashi, Minato-ku, Tokyo
TEL
03-5408-8181
h-sugimura@shinkokai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kirin 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
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
| 2014 | Year | 05 | Month | 30 | 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
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2015 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016431
