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Completed

NCT Number: NCT02824614

Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

E967-Xylitol

Dietary Supplement

Other names: Xylitol

E968-Erythritol

Dietary Supplement

Other names: Erythritol

Primary outcomes

  1. Glucose tolerance measured with oral glucose tolerance test

    Time frame: change from baseline to 8 weeks after polyol intake

Secondary outcomes

  1. Human gut microbiota composition measured with metagenomic shotgun sequencing

    Time frame: change from baseline to 8 weeks after polyol intake

  2. Gut microbial-related metabolites in feces

    Time frame: 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

  3. Gastrointestinal tolerance assessed by questionnaire

    Time frame: change from baseline to 8 weeks after polyol intake

    Gastrointestinal Symptoms Rating Scale (Svedlund et al)

  4. Gut microbial-related metabolites in urine

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2016
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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