UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023986
Receipt No. R000027586
Scientific Title A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Date of disclosure of the study information 2016/10/20
Last modified on 2018/08/15

* 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
Public title A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Acronym A study of healthy adult males in a crossover comparison trial of noodles containing 0 grams of sugar vs commercially available noodles
Scientific Title A study of healthy adult males in a crossover comparison trial of postprandial blood glucose levels regarding noodles containing 0 grams of sugar and commercially available noodles.
Scientific Title:Acronym A study of healthy adult males in a crossover comparison trial of noodles containing 0 grams of sugar vs commercially available noodles
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Regarding postprandial blood glucose levels of humans for noodles containing 0 grams of sugar, it was found that postprandial blood glucose levels do not rise easily when compared with commercially available noodles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose level
Key secondary outcomes Insulin

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 noodles containing 0 grams of sugar
Interventions/Control_2 commercially available noodles
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
35 years-old >=
Gender Male
Key inclusion criteria 1)Healthy adult males
Age:20 years old -35 years old
2)Blood glucose level:60-110mg/dL
3)Syphilis(-),HIV(-),HBsAg(-),HCV(-)
4)Written informed consent
Key exclusion criteria 1)People with an allergy towards wheat, soybean and ingredients from other experimental diets
2)People who regularly take supplements, health products and specified health foods that have an effect on blood sugar levels
3)People with Serious complications
4)People with Psychiatric disorder
5)People who participated in other trial within 4 months
6)People who judged inappropriate for this study by the treating physician

Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Tsunematsu
Organization Kitasato University Kitasato Institute Hospital
Division name Department of Research
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-5791-6350
Email tunematu@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Takenaga
Organization Kitasato Academic Research Organization, Kitasato University
Division name Clinical Trial Coordinating Center
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-5791-6400
Homepage URL
Email takena-t@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization KIBUN FOODS INC
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 北里大学北里研究所病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 20 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
2016 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2016 Year 11 Month 09 Day
Date of closure to data entry
2016 Year 11 Month 20 Day
Date trial data considered complete
2016 Year 11 Month 25 Day
Date analysis concluded
2016 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 09 Day
Last modified on
2018 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.