UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000014115
Receipt No. R000016431
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Study of Effect of Food Containing Resistant Maltodextrin on Postprandial Serum Triglyceride
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Haruhi Sugimura
Organization C'est la vie Shinbashi Clinic
Division name Medical office
Address 2-39-3 Nishishinbashi, Minato-ku, Tokyo
TEL 03-5408-8181
Email h-sugimura@shinkokai.jp

Public contact
Name of contact person Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016431


Contact us.