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

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Bacillus subtilis var natto DC-15
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo (flour)

Bacillus subtilis var natto DC-15

Arm Description

5 placebo capsules for each test (4.88 kcal/5 cap)

5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15

Outcomes

Primary Outcome Measures

Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2014
Last Updated
August 17, 2015
Sponsor
Hiroshima University
Collaborators
NewBio Enterprise Co., ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02300181
Brief Title
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose
Official Title
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of the Flour Fermentation Products by Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose Profile in Prediabetic Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
NewBio Enterprise Co., ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (flour)
Arm Type
Placebo Comparator
Arm Description
5 placebo capsules for each test (4.88 kcal/5 cap)
Arm Title
Bacillus subtilis var natto DC-15
Arm Type
Experimental
Arm Description
5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Bacillus subtilis var natto DC-15
Primary Outcome Measure Information:
Title
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
Time Frame
Overall 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumiko Higashikawa, PhD
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

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

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