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

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Dietary Supplement: Bacillus subtilis var natto DC-15; Dietary Supplement: Placebo

• Registration Number: NCT02300181
• Lead Sponsor: Hiroshima University

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 available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bacillus subtilis var natto DC-15	Bacillus subtilis var natto DC-15	5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15
Placebo (flour)	Placebo	5 placebo capsules for each test (4.88 kcal/5 cap)

Primary Outcome Measures

Name	Time	Method
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.	Overall 3 hours

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan