Resistant Starch, Gut Bacteria and Diabetes (RSDD)
Primary Purpose
Diabetes Mellitus, Type 2, Pre Diabetes
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SymbioIntest
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring resistant starch type III, butyrate-producing gut bacteria, diabetes mellitus type 2, prediabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Institute of Clinical Nutrition
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
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.
Outcomes
Primary Outcome Measures
Change of gut bacteria
quantitative Analyse with Next-Generation Sequencing
Change of short chain fatty acid concentration in the gut
gas chromatography
Secondary Outcome Measures
change from baseline in HbA1c at four weeks and eight weeks after consumption resistant starch type III
change from baseline in insulin at four weeks and eight weeks after consumption resistant starch type III
change from baseline in blood glucose at four weeks and eight weeks after consumption resistant starch type III
Change from baseline in anthropometry at four weeks and eight weeks after consumption resistant starch type III
Full Information
NCT ID
NCT03057444
First Posted
February 15, 2017
Last Updated
October 25, 2018
Sponsor
University of Hohenheim
Collaborators
Institut für Mikroökologie GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03057444
Brief Title
Resistant Starch, Gut Bacteria and Diabetes
Acronym
RSDD
Official Title
Influence of Resistant Starch Type III on Butyrate-producing Gut Bacteria and Diabetes Parameter in (Pre-) Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hohenheim
Collaborators
Institut für Mikroökologie GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Pre Diabetes
Keywords
resistant starch type III, butyrate-producing gut bacteria, diabetes mellitus type 2, prediabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
SymbioIntest
Intervention Description
The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
Primary Outcome Measure Information:
Title
Change of gut bacteria
Description
quantitative Analyse with Next-Generation Sequencing
Time Frame
Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Title
Change of short chain fatty acid concentration in the gut
Description
gas chromatography
Time Frame
Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
Change from baseline in PYY (Peptide YY) at four weeks and eight weeks after consumption resistant starch type III
Description
with ELISA
Time Frame
Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
Title
Change from baseline in GLP-1 (Glucagon-like peptide-1) at four weeks and eight weeks after consumption resistant starch type III
Description
with ELISA
Time Frame
Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C. Bischoff, Prof.
Organizational Affiliation
University of Hohenheim, 70599 Stuttgart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Clinical Nutrition
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70599
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Resistant Starch, Gut Bacteria and Diabetes
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