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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
Institute of Clinical Nutrition
Stuttgart, Baden-Wurttemberg, Germany
Change of gut bacteria
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
Change of short chain fatty acid concentration in the gut
gas chromatography
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 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
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