UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022121
Receipt No. R000025360
Scientific Title A Study on the Effect of Food Containing Polydextrose on Postprandial Blood Glucose -A Randomized, Double-blind,Placebo-controlled, Cross-over Study-
Date of disclosure of the study information 2016/05/02
Last modified on 2020/04/20 (Ver. 5)

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Basic information
Public title A Study on the Effect of Food Containing Polydextrose on Postprandial Blood Glucose
-A Randomized, Double-blind,Placebo-controlled, Cross-over Study-
Acronym The Effect of Food Containing Polydextrose on Postprandial Blood Glucose
Scientific Title A Study on the Effect of Food Containing Polydextrose on Postprandial Blood Glucose
-A Randomized, Double-blind,Placebo-controlled, Cross-over Study-
Scientific Title:Acronym The Effect of Food Containing Polydextrose on Postprandial Blood Glucose
Region
Japan

Condition
Condition No(Borderline diabetes)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To comfirm the effect of food containing polydextrose on postprandial blood glucose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial blood glucose AUC
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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 polydextrose, 1 per serving
Interventions/Control_2 Food not containing polydextrose, 1 per serving
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) males and females aged 20 to 64 years old.
(2) Subjects whose fasting blood glucose level are from 110 mg/dL to 125 mg/dL or 2-hour glucose value in a 75 g oral glucose tolerance test are from 140 mg/dL to 199 mg/dL, and who are judged as borderline diabetes by the investigator.
(3) Subjects who don't habitually consume a large amount of alcohol.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria (1) Subjects who use oral medications affecting blood glucose.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood glucose during test periods.
(3) Subjects who have declared allergic reaction to test foods or ingredients contained in loading foods.
(4) Subjects who are diagnosed as diabetes based on the results of screening test.
(5) Subjects who contract, are under treatment for or have a history of serious diseases (e.g., diabetes, kidney disease, liver disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(6) Subjects who have a chronic disease and use medications continuously.
(7) Subjects who have a history of digestive disease affecting digestion and absorption.
(8) Subjects who are judged as unsuitable for the current study based on the results of screening test.
(9) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(10) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(12) Subjects who are planning to participate in other clinical studies.
(13) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating.
(14) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Target sample size 50

Research contact person
Name of lead principal investigator
1st name Haruhi
Middle name
Last name Sugimura
Organization Shinkokai
Division name Medical office
Zip code 105-0003
Address 2-39-3 Nishishimbashi, Minato-ku, Tokyo
TEL 03-5408-8181
Email h-sugimura@shinkokai.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU 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 Ethical Committee of C'est la vie Shimbashi Clinic
Address 2-39-3 Nishishimbashi,Minato-ku, Tokyo
Tel 03-5408-8671
Email m-fujii@shinkokai.jp

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
2016 Year 05 Month 02 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000025360
Publication of results Published

Result
URL related to results and publications http://www.medicalonline.jp/journal/info?GoodsID=ef4oyoya/2016/009103/002&name=0061-0067j
Number of participants that the trial has enrolled 50
Results 
Statistically significant difference was confirmed in the primary outcome.
Results date posted
2020 Year 04 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Males and females aged 20 to 64 years old.
Participant flow 
Enrolled(n=50)
Completed(n=49)
Analysed(n=43)
Adverse events 
No adverse events were observed that be related to test food.
Outcome measures 
Postprandial blood glucose AUC
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
2016 Year 04 Month 20 Day
Anticipated trial start date
2016 Year 05 Month 07 Day
Last follow-up date
2016 Year 06 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 28 Day
Last modified on
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025360