Resistant Starch, Gut Bacteria and Diabetes (RSDD)

• ClinicalTrials.gov Identifier: NCT03057444
• Recruitment Status: Completed
• First Posted: February 20, 2017
• Last Update Posted: October 26, 2018
• Sponsor: University of Hohenheim
• Collaborator: Institut für Mikroökologie GmbH
• Information provided by (Responsible Party): University of Hohenheim

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Pre Diabetes	Dietary Supplement: SymbioIntest	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: open intervention study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Resistant Starch Type III on Butyrate-producing Gut Bacteria and Diabetes Parameter in (Pre-) Diabetes
• Actual Study Start Date: February 10, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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. ]
2. 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. ]
3. 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 ]
4. 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 Outcome Measures:

1. Change from baseline in PYY (Peptide YY) 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. ]
   with ELISA
2. Change from baseline in GLP-1 (Glucagon-like peptide-1) 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. ]
   with ELISA

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Institute of Clinical Nutrition

Stuttgart, Baden-Württemberg, Germany, 70599

Sponsors and Collaborators

University of Hohenheim

Institut für Mikroökologie GmbH

Investigators

• Principal Investigator: Stephan C. Bischoff, Prof.; University of Hohenheim, 70599 Stuttgart

More Information

• Responsible Party: University of Hohenheim
• ClinicalTrials.gov Identifier: NCT03057444
• Other Study ID Numbers: UniHohMet-RSIII-2016
• First Posted: February 20, 2017
• Last Update Posted: October 26, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Hohenheim:

resistant starch type III; butyrate-producing gut bacteria; diabetes mellitus type 2; prediabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases