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Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117802
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
André Marette, Laval University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight Microbiota Endotoxemia Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Insulin Resistance Other: Maple syrup Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : January 29, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Maple Other: Maple syrup
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 Comparator: Placebo Other: Placebo
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 Outcome Measures :
  1. Change in Gut Microbiota Composition and Diversity [ Time Frame: Change between the beginning and the end of each treatment (8 weeks each) ]
    Global variation of the fecal microbiota


Secondary Outcome Measures :
  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 plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test

  8. Change in Glucose homeostasis [ Time Frame: Change between the beginning and the end of each treatment (8 weeks each) ]
    Evaluation of glycated haemoglobin

  9. 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

  10. 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

  11. Change in anthropometric measurements [ Time Frame: Change between the beginning and the end of each treatment (8 weeks each) ]
    Evaluation of waist circumference

  12. 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

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117802


Contacts
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Contact: Julie Marois, M.Sc. 1-418-656-2131 ext 405764 julie.marois@fsaa.ulaval.ca

Locations
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Canada
INAF, Université Laval Recruiting
Québec, Canada, G1V 0A6
Contact: Julie Marois, M.Sc.    1-418-656-2131 ext 405764    julie.marois@fsaa.ulaval.ca   
Sponsors and Collaborators
Laval University

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Responsible Party: André Marette, Professor, Laval University
ClinicalTrials.gov Identifier: NCT04117802    
Other Study ID Numbers: ERABLE-21793
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endotoxemia
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Insulin Resistance
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation