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

Prediabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300181
• Other study ID #: eki-1051
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: August 17, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetes

Intervention

Dietary Supplement:
• Placebo

• Bacillus subtilis var natto DC-15

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	NewBio Enterprise Co., ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.		Overall 3 hours	No