Effect of the Extract of the Flour Fermented With Bacillu... | NCT02300181

Studies
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose

NCT02300181

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Prediabetes

Interventions

Placebo
Bacillus subtilis var natto DC-15

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Nov 20, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Name	Class
NewBio Enterprise Co., ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects with prediabetes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo (flour)	Placebo Comparator	5 placebo capsules for each test (4.88 kcal/5 cap)	Dietary Supplement: Placebo
Bacillus subtilis var natto DC-15	Experimental	5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15	Dietary Supplement: Bacillus subtilis var natto DC-15

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement		Placebo (flour)
Bacillus subtilis var natto DC-15

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.		Overall 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

Taking anti-diabetic drugs
Taking drugs or functional food that may affect blood glucose level
Pregnant or nursing a child
Participation in any clinical trial within 90 days of the commencement of the trial
Renal or hepatic dysfunction
Heart disease
History of severe disease and/or major surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fumiko Higashikawa, PhD	Hiroshima University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		734-8551	Japan

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided