Proof of concept study to investigate the impact of a food supplement consisting of Acacia gum on changes of gut microbiota and production of short chain fatty acids. Additionally, safety, tolerability and parameters of bowel function (stool frequency, stool consistency and gastrointestinal symptoms) will be assessed during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Two sachets (à 5 g) in the morning and two sachets in the evening, reconstituted in 120 ml water and stirred until fully dissolved to be taken 10 minutes before meals.
BioTeSys GmbH
Esslingen am Neckar, Germany
Gut microbiota
Composition and diversity (Shannon index), Lactobacillogenic and bifidogenic level, Distribution of bacterial taxa at the phylum, family and genus level, Shifts of specific bacterial taxa
Time frame: day 1, day 43 and day 71
Stool frequency
frequency per week will be assessed via diary
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Stool consitency
consistency will be assessed via Bristol Stool Form Scale
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Gastrointestinal symptoms
Global Gastrointestinal Discomfort Assessment (PAC-SYM), single gastrointestinal symptoms (flatulence, rumbling (i.e. borborygmi)), layative use
Time frame: day -14 (run-in phase) until day 70 (end of follow up)
Blood biomarker
Lipid profile (total, HDL- and LDL- cholesterol and triglycerides) Blood glucose Electrolytes and minerals (plasma sodium, potassium and calcium) SCFA (short chain fatty acids) (optional) Cytokines: IL-10 \& IL-6 (optional)
Time frame: day 1, day 43 and day 71
Stool biomarker
SCFA (short chain fatty acids) Zonulin Calprotectin (optional) Secretory IgA (optional) Beta-defensin (optional) Bile acids (optional) Nitric oxide (optional)
Time frame: day 1, day 43 and day 71
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