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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032974
Receipt No. R000037598
Official scientific title of the study Clinical Pharmacology Study for Noodle Containing Calcium Alginate-Additional study A -
Date of disclosure of the study information 2018/06/14
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Clinical Pharmacology Study for Noodle Containing Calcium Alginate-Additional study A -
Title of the study (Brief title) Clinical Pharmacology Study for Noodle Containing Calcium Alginate-Additional study A -
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of noodle A containing calcium alginate on blood glcose level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose of profile after meal
Key secondary outcomes Blood IRI,Total-cholesterol,HDL-cholesterol,LDL-cholesterol,UA,BUN and Ca level

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
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 Noodle A containing calcium alginate.
washout(3 days or more between arms).
Noodle A containing no calcium alginate.
Interventions/Control_2 Noodle A containing no calcium alginate.
Washout(3 days or more between arms).
Noodle A containing calcium alginate.
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)man or womam whose age is Over 35 years old or older.
2)Those who gave written consent.
3)Those who can Comply with ptorcal restrictions for meal and exercise.
4)Those who have no allergy to wheat and buckwheat.
5)Those who have not been clinically diagnosed with diabetes.
6)Those who can Comply with Instructions from the Investigators.
7)Those who can keep Confidentiality of the content of the trial.
Key exclusion criteria 1)Those who have allergic symptoms to alcohol.
2)Those who are suspected not to have intact gut absorption.
3)Those whose HbA1c(NGSP) is higher than 6.5%.
4)those who are considered as inappropriate for this study by the investigators.
Target sample size 20

Research contact person
Name of lead principal investigator Shoichiro Ohta
Organization Fukushima Medical University
Division name school of Nursing
Address 1,Hikarigaoka,Hukusima-shi,Hukusima
TEL 024-547-1872
Email sohtajp@fmu.ac.jp

Public contact
Name of contact person Akihiro Inano
Organization Fukushima Medical University
Division name Clinical Research Center
Address 1,Hikarigaoka,Hukusima-shi,Hukusima
TEL 024-547-1774
Homepage URL
Email ainano@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Shimadaya Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Takasaki University of Health and Welfare
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 福島県立医科大学附属病院(福島県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 Day

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 11 Day
Anticipated trial start date
2018 Year 06 Month 24 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
2018 Year 06 Month 13 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037598

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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