Obesity
Conditions
Brief summary
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.
Interventions
DIETARY_SUPPLEMENTE967-Xylitol
DIETARY_SUPPLEMENTE968-Erythritol
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Mullti-center trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Obese volunteers (BMI \> 30kg/m2) * Aged 18- max. 55 years * Otherwise healthy.
Exclusion criteria
* Known cardiovascular disease * Diabetes mellitus * Arterial Hypertension with medication * Dyslipidaemia with medication * Known chronic hepatic disease (NASH, hepatitis). * Known renal disease: kidney failure * Pregnancy * Intake of proton pump inhibitors (PPIs) on a regular basis * Intake of antibiotics within the last 3 months before inclusion * Intake of pro or prebiotics * Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract * Substance abuse, alcohol abuse. * Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose tolerance measured with oral glucose tolerance test | change from baseline to 8 weeks after polyol intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human gut microbiota composition measured with metagenomic shotgun sequencing | change from baseline to 8 weeks after polyol intake | — |
| Gut microbial-related metabolites in feces | change from baseline to 8 weeks after polyol intake | Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry |
| Gastrointestinal tolerance assessed by questionnaire | change from baseline to 8 weeks after polyol intake | Gastrointestinal Symptoms Rating Scale (Svedlund et al) |
| Gut microbial-related metabolites in urine | change from baseline to 8 weeks after polyol intake | Metabolomic analysis of the bacterial metabolites present in the urine by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry |
Countries
Norway, Russia, Switzerland
Outcome results
None listed