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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02300181

Enrollment

Registered

2014-11-24

Start date

2014-10-31

Completion date

2015-03-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

DIETARY_SUPPLEMENTBacillus subtilis var natto DC-15

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026