Skip to main content
OpenTrials
Completed

NCT Number: NCT04117802

Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

It has been suggested that the actual obesity epidemy is related to chronic overconsumption of added or free sugars. The increasing popularity of artificial sweeteners attest the population willingness to reduce added sugars intake and to use alternatives to alleviate health impact of free sugar overconsumption. However, recent findings suggest that artificial sweeteners may rather contribute to obesity epidemy and its associated adverse health effects, potentially via a negative impact on gut microbiota. It has been shown in various studies that, for the same amount of sucrose, unrefined sugars (such as maple syrup) are associated with favorable metabolic effects. The polyphenols contained in maple syrup, especially lignans, could contribute to these positive effects. Indeed, the strong impact of those biomolecules on the modulation of gut microbiota and on gastro-intestinal and metabolic health has been demonstrated in several studies. It is therefore highly relevant to test the hypothesis that the substitution of refined sugar by an equivalent amount of maple syrup (5% of daily energy intake) result in a lesser metabolic deterioration, by the modulation of maple syrup on gut microbiota, than the one observed with refined sugar.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Bacteremia Body Weight Digestive System Diseases Endotoxemia Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Infections Inflammation Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Microbiota Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAF, Université Laval

Québec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI between 23 and 40 kg/m2
  • At least one of the following: Fasting triglyceride > 1,35 mmol/L, Fasting insulinemia > 42 pmol/L, fasting glycemia between 5,5 and 6,9 mmol/L and glycated haemoglobin (HbA1c) between 5.7 and 6.4 %
  • Understanding of spoken and written french
  • Accept to follow study instructions
  • If there is natural health product consumption, the dose and frequency of consumption must be stable since 3 months or more

Exclusion criteria

  • Smoking
  • Any metabolic disorder requiring medication or affecting glucose or lipid metabolism
  • Aversion for maple taste
  • Allergy or intolerance for maple syrup or for an ingredient of the placebo syrup
  • Alcohol consumption of > 2 drinks / day
  • Weight change > 5% of body weight in the last 3 months
  • Being in a weight loss attempt
  • Antibiotics intake in the last 3 months
  • Regular probiotics intake in the last 3 months
  • Major surgical operation in the last 3 months or planned in the next months
  • Gastrointestinal malabsorption
  • Cirrhosis
  • Chronic kidney disease
  • Pregnant or breastfeeding women or women planning pregnancy in the next months
  • Participation in another clinical trial

Treatment and study plan

Maple syrup

Other

Substitution of refined sugar by an equivalent quantity of maple syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with maple syrup.

Placebo

Other

Substitution of refined sugar by an equivalent quantity of maple-flavored sucrose syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with the placebo (sucrose syrup).

Primary outcomes

  1. Change in Glucose homeostasis

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test

Secondary outcomes

  1. Change in Endotoxemia

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)

  2. Change in Intestinal permeability

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Plasma zonulin

  3. Change in Inflammation state of the tissue

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Fecal calprotectin and chromogranin

  4. Change in Short chain fatty acids in the feces

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Measure short chain fatty acids in the feces

  5. Change in Gut health and stool consistency

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires (the gastrointestinal symptom rating scale (GSRS) and Bristol stool chart)

  6. Change in fat accumulation in the liver

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of fat accumulation by magnetic resonance imaging (MRI)

  7. Change in Glucose homeostasis

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of glycated haemoglobin

  8. Change in Lipid profile

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids end of two dietary treatment

  9. Change in anthropometric measurements

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of bmi with weight and height measurements

  10. Change in anthropometric measurements

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of waist circumference

  11. Change in body composition

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of body composition by osteodensitometry

  12. Change in chronic inflammation

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)

  13. Change in gene expression levels

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Transcriptomic analyses to investigate underlying mechanisms of action

  14. Change in circulating levels of plasma metabolites

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Metabolomic analyses to investigate underlying mechanisms of action

  15. Change in maple-derived metabolites present in stool

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds

  16. Change in blood pressure

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Evaluation of systolic and diastolic blood pressure

  17. Change in Gut Microbiota Composition

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Gut microbiota composition will be evaluated by 16S rRNA amplicon sequencing (V3-V4 region)

  18. Change in Gut Microbiota Composition

    Time frame: Change between the beginning and the end of maple syrup treatment (8 weeks)

    Gut microbiota composition will also be evaluated by whole genome sequencing

  19. Change in Gut Microbiota alpha Diversity

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    To quantify bacterial alpha diversity, Shannon's reciprocal index will be calculated

  20. Change in Gut Microbiota alpha Diversity

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    To quantify bacterial alpha diversity, Simpson's reciprocal index will be calculated

  21. Change in Gut Microbiota beta Diversity

    Time frame: Change between the beginning and the end of each treatment (8 weeks each)

    Principal component analysis (PCA) will be performed on the Aitchison distance matrix to measure beta diversity.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2019
Registry last updated
Apr 15, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.