PrediabetesNCT02300181
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose
A study testing Bacillus subtilis var natto DC-15 in people with Prediabetes, run by Hiroshima University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Bacillus subtilis var natto DC-15
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose 110-125 mg/dL
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Prediabetes
- Being tested
- Placebo, Bacillus subtilis var natto DC-15
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Bacillus subtilis var natto DC-15Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo (flour) | Placebo comparator | 5 placebo capsules for each test (4.88 kcal/5 cap) Receives: 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 Receives: Dietary Supplement: Bacillus subtilis var natto DC-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
Measured: Overall 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- NewBio Enterprise Co., ltd.
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300181
- Sponsor's protocol ID
- eki-1051
- Status last verified
- Aug 2015
- First submitted
- 20 Nov 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02300181
- Acronym / sponsor ID
- eki-1051
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- NewBio Enterprise Co., ltd.
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (flour) | Placebo comparator | Dietary Supplement: Placebo5 placebo capsules for each test (4.88 kcal/5 cap) |
| Bacillus subtilis var natto DC-15 | Experimental | Dietary Supplement: Bacillus subtilis var natto DC-155 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting plasma glucose 110-125 mg/dL
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Placebo (flour) |
| Bacillus subtilis var natto DC-15 | Dietary supplement | Bacillus subtilis var natto DC-15 |
Primary outcome
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
Time frame: Overall 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus subtilis var natto DC-15 in people with Prediabetes, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate. (time frame: Overall 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.