NCT02300181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

November 20, 2014

Last Update Submit

August 17, 2015

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

  • Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.

    Overall 3 hours

Study Arms (2)

Placebo (flour)

PLACEBO COMPARATOR

5 placebo capsules for each test (4.88 kcal/5 cap)

Dietary Supplement: Placebo

Bacillus subtilis var natto DC-15

EXPERIMENTAL

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

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo (flour)
Bacillus subtilis var natto DC-15DIETARY_SUPPLEMENT
Bacillus subtilis var natto DC-15

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting plasma glucose 110-125 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

JP(1)