Resistant Starch, Gut Bacteria and Diabetes (RSDD)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Pre Diabetes
• Intervention / Treatment: Dietary supplement: SymbioIntest

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • Institute of Clinical Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Dietary supplement: SymbioIntest; The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of gut bacteria	quantitative Analyse with Next-Generation Sequencing	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	Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week

Secondary Outcome Measures

Outcome Measure	Time Frame
change from baseline in HbA1c at four weeks and eight weeks after consumption resistant starch type III	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	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	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	Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in PYY (Peptide YY) at four weeks and eight weeks after consumption resistant starch type III	with ELISA	Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.
Change from baseline in GLP-1 (Glucagon-like peptide-1) at four weeks and eight weeks after consumption resistant starch type III	with ELISA	Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: Institut für Mikroökologie GmbH
• Investigators: Principal Investigator: Stephan C. Bischoff, Prof., University of Hohenheim, 70599 Stuttgart

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: prediabetes; diabetes mellitus type 2; resistant starch type III; butyrate-producing gut bacteria
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: UniHohMet-RSIII-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No