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

H

Hiroshima University

Status

Completed

Conditions

Prediabetes

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Bacillus subtilis var natto DC-15

Study type

Interventional

Funder types

Other

Identifiers

NCT02300181
eki-1051

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

35 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Placebo (flour)
Placebo Comparator group
Description:
5 placebo capsules for each test (4.88 kcal/5 cap)
Treatment:
Dietary Supplement: Placebo
Bacillus subtilis var natto DC-15
Experimental group
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
Treatment:
Dietary Supplement: Bacillus subtilis var natto DC-15

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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