Resistant Starch, Gut Bacteria and Diabetes

NCT03057444 | Completed

• 1 other identifier: UniHohMet-RSIII-2016
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Pre Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Outcomes (2)

• Change from baseline in PYY (Peptide YY) 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 GLP-1 (Glucagon-like peptide-1) 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.

Study Arms (1)

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.

Dietary Supplement: SymbioIntest

Interventions

SymbioIntest DIETARY_SUPPLEMENT

The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hohenheim: lead
• Institut für Mikroökologie GmbH: collaborator

Study Sites (1)

Institute of Clinical Nutrition

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Stephan C. Bischoff, Prof.

  University of Hohenheim, 70599 Stuttgart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open intervention study

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: February 10, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)