Diabetes Mellitus, Type 2RSDDNCT03057444
Resistant Starch, Gut Bacteria and Diabetes
A study testing SymbioIntest in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by University of Hohenheim at 1 site in Germany.
Trial summary
The aim of the study is to investigate, if resistant starch type III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters are also of interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre Diabetes
- What is being tested?
- SymbioIntest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2017to 31 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult persons (≥ 18 years)
- Type 2 diabetes mellitus discontinued with lifestyle interventions or insulin therapy or oral antidiabetic therapy (sulphonylureas, glinides, SGLT-2 (sodium/glucose cotransporter 2) inhibitors, glitazone) or a prediabetic metabolism
- It is foreseeable that no therapy with metformin or α-glucosidase inhibitors or DPP-4 (Dipeptidyl peptidase-4) inhibitors is initiated during the period of study (8 weeks)
- willingness not to systematically change diet and lifestyle habits during the study
- Adequate understanding of the German language and sufficient psychological condition to understand the information and instructions associated with the study and to complete questionnaires and assessment scales
- Signed informed consent
Who cannot join
- Treatment of Type II diabetes mellitus by metformin or α-glucosidase inhibitors or DPP-4 inhibitors
- Diminished diabetic metabolic position or medical necessity to convert the therapy in the foreseeable future (HbA1c ≥ 7% or fasting glucose ≥ 152 mg / dl)
- Participation in another clinical trial (currently or within the last 30 days)
- Incompatibility with the ingredients of the investigational medicinal product
- Pregnancy or lactation
- Inability to take the test preparation orally
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- changes in dietary habits and habits within the last 30 days
- Antibiotics intake currently or within the last 30 days
- Drug abuse in the last six months before the start of the study or ongoing. Alcohol abuse is defined as an average daily of more than 20 g of alcohol in women and more than 30 g of alcohol in men, based on the last six months
- A state of health (including abnormal laboratory values) that, at the discretion of the investigator, does not allow study participation, evaluation of study parameters or the use of the investigational medicinal product
- Accommodation in a clinic or similar facility, by administrative or judicial order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Nutrition
Stuttgart, Baden-Wurttemberg, 70599
About this study
Official title: Influence of Resistant Starch Type III on Butyrate-producing Gut Bacteria and Diabetes Parameter in (Pre-) Diabetes
The aim of the study is to investigate, if resistant starch type III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters are also of interest.
Read the detailed description
Other studies show that diabetics have less butyrate-producing bacteria species in the gut compared to non-diabetes patients and diabetes patients who are taking metformin. Moreover, studies demonstrate that resistant starch increases the butyrate-producing bacteria species. Furthermore, studies show that butyrate has on effect on blood glucose and insulin homeostasis.
The aim in this study is to investigate, if resistant starch typ III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects, The effects on blood glucose, insulin and HbA1c are investigated as well.
Patients included in the study are typ 2 diabetics with lifestyle interventions, insulin or antidiabetic medication (sulfonylureas, glinides, SGLT2-inhibitors, glitazone) or pre-diabetics.
They get 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
Study examinations are before intervention, after 4 weeks and 8 weeks. Stool samples are collected before intervention and each 14 days consecutively until the end of intervention.
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Being tested
- SymbioIntest
- Keywords
- resistant starch type III, butyrate-producing gut bacteria, diabetes mellitus type 2, prediabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioIntestDietary supplement
The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients get 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
Study examinations are before intervention, after 4 weeks and 8 weeks. Stool samples are collected before intervention and each 14 days consecutively until the end of intervention. Receives: Dietary Supplement: SymbioIntest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gut bacteria
quantitative Analyse with Next-Generation Sequencing
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Change of short chain fatty acid concentration in the gut
gas chromatography
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Secondary outcomes (4)
change from baseline in HbA1c at four weeks and eight weeks after consumption resistant starch type III
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
change from baseline in insulin at four weeks and eight weeks after consumption resistant starch type III
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
change from baseline in blood glucose at four weeks and eight weeks after consumption resistant starch type III
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Change from baseline in anthropometry at four weeks and eight weeks after consumption resistant starch type III
Measured: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start10 Feb 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open intervention study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Mikroökologie GmbH
- Responsible party
- Sponsor
- Investigators
- Stephan C. Bischoff, Prof., Principal investigator, University of Hohenheim, 70599 Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057444
- Sponsor's protocol ID
- UniHohMet-RSIII-2016
- Acronym
- RSDD
- Status last verified
- Oct 2018
- First submitted
- 15 Feb 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Resistant Starch Type III on Butyrate-producing Gut Bacteria and Diabetes Parameter in (Pre-) Diabetes
- ClinicalTrials.gov ID
- NCT03057444
- Acronym / sponsor ID
- RSDD / UniHohMet-RSIII-2016
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Keywords
- resistant starch type III, butyrate-producing gut bacteria, diabetes mellitus type 2, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Institut für Mikroökologie GmbH
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 20 Feb 2017 (actual)
- 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 aim of the study is to investigate, if resistant starch type III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters are also of interest.
Detailed description
Other studies show that diabetics have less butyrate-producing bacteria species in the gut compared to non-diabetes patients and diabetes patients who are taking metformin. Moreover, studies demonstrate that resistant starch increases the butyrate-producing bacteria species. Furthermore, studies show that butyrate has on effect on blood glucose and insulin homeostasis.
The aim in this study is to investigate, if resistant starch typ III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects, The effects on blood glucose, insulin and HbA1c are investigated as well.
Patients included in the study are typ 2 diabetics with lifestyle interventions, insulin or antidiabetic medication (sulfonylureas, glinides, SGLT2-inhibitors, glitazone) or pre-diabetics.
They get 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
Study examinations are before intervention, after 4 weeks and 8 weeks. Stool samples are collected before intervention and each 14 days consecutively until the end of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open intervention study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: SymbioIntestThe patients get 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks. Study examinations are before intervention, after 4 weeks and 8 weeks. Stool samples are collected before intervention and each 14 days consecutively until the end of intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adult persons (≥ 18 years)
- Type 2 diabetes mellitus discontinued with lifestyle interventions or insulin therapy or oral antidiabetic therapy (sulphonylureas, glinides, SGLT-2 (sodium/glucose cotransporter 2) inhibitors, glitazone) or a prediabetic metabolism
- It is foreseeable that no therapy with metformin or α-glucosidase inhibitors or DPP-4 (Dipeptidyl peptidase-4) inhibitors is initiated during the period of study (8 weeks)
- willingness not to systematically change diet and lifestyle habits during the study
- Adequate understanding of the German language and sufficient psychological condition to understand the information and instructions associated with the study and to complete questionnaires and assessment scales
Key exclusion criteria (11 listed)
- Treatment of Type II diabetes mellitus by metformin or α-glucosidase inhibitors or DPP-4 inhibitors
- Diminished diabetic metabolic position or medical necessity to convert the therapy in the foreseeable future (HbA1c ≥ 7% or fasting glucose ≥ 152 mg / dl)
- Participation in another clinical trial (currently or within the last 30 days)
- Incompatibility with the ingredients of the investigational medicinal product
- Pregnancy or lactation
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 |
|---|---|---|
| SymbioIntestThe intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks. | Dietary supplement | Intervention group |
Primary outcome
Change of gut bacteria
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
quantitative Analyse with Next-Generation Sequencing
Change of short chain fatty acid concentration in the gut
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
gas chromatography
4 secondary outcomes
change from baseline in HbA1c at four weeks and eight weeks after consumption resistant starch type III
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
change from baseline in insulin at four weeks and eight weeks after consumption resistant starch type III
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
change from baseline in blood glucose at four weeks and eight weeks after consumption resistant starch type III
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Change from baseline in anthropometry at four weeks and eight weeks after consumption resistant starch type III
Time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
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 26 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Stephan C. Bischoff, Prof. principal investigator
University of Hohenheim, 70599 Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SymbioIntest in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by University of Hohenheim at 1 site in Germany.
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 6 inclusion and 11 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 26 Oct 2018. 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 Germany. 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. 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?
Change of gut bacteria (time frame: Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week). The study lists 2 primary outcomes in all. 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 26 Oct 2018.