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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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ClinicalTrials.gov Identifier: NCT02300181
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : August 19, 2015
Sponsor:
Collaborator:
NewBio Enterprise Co., ltd.
Information provided by (Responsible Party):
Fumiko Higashikawa, 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.

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: Placebo Dietary Supplement: Bacillus subtilis var natto DC-15 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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



Primary Outcome Measures :
  1. Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate. [ Time Frame: Overall 3 hours ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300181


Locations
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Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
NewBio Enterprise Co., ltd.
Investigators
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Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University

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Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT02300181     History of Changes
Other Study ID Numbers: eki-1051
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases