Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
Primary Purpose
Overweight, Microbiota, Endotoxemia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Maple syrup
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility 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
Sites / Locations
- INAF, Université Laval
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Maple
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Gut Microbiota Composition and Diversity
Global variation of the fecal microbiota
Secondary Outcome Measures
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Change in Intestinal permeability
Plasma zonulin
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Change in Short chain fatty acids in the feces
Measure short chain fatty acids in the feces
Change in Gut health and stool consistency
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires (the gastrointestinal symptom rating scale (GSRS) and Bristol stool chart)
Change in fat accumulation in the liver
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Change in Glucose homeostasis
Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test
Change in Glucose homeostasis
Evaluation of glycated haemoglobin
Change in Lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids end of two dietary treatment
Change in anthropometric measurements
Evaluation of bmi with weight and height measurements
Change in anthropometric measurements
Evaluation of waist circumference
Change in body composition
Evaluation of body composition by osteodensitometry
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Change in gene expression levels
Transcriptomic analyses to investigate underlying mechanisms of action
Change in circulating levels of plasma metabolites
Metabolomic analyses to investigate underlying mechanisms of action
Change in maple-derived metabolites present in stool
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Change in blood pressure
Evaluation of systolic and diastolic blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04117802
Brief Title
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
Official Title
Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Microbiota, Endotoxemia, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maple
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Maple syrup
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Change in Gut Microbiota Composition and Diversity
Description
Global variation of the fecal microbiota
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Secondary Outcome Measure Information:
Title
Change in Endotoxemia
Description
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Intestinal permeability
Description
Plasma zonulin
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Inflammation state of the tissue
Description
Fecal calprotectin and chromogranin
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Short chain fatty acids in the feces
Description
Measure short chain fatty acids in the feces
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Gut health and stool consistency
Description
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires (the gastrointestinal symptom rating scale (GSRS) and Bristol stool chart)
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in fat accumulation in the liver
Description
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Glucose homeostasis
Description
Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Glucose homeostasis
Description
Evaluation of glycated haemoglobin
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in Lipid profile
Description
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids end of two dietary treatment
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in anthropometric measurements
Description
Evaluation of bmi with weight and height measurements
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in anthropometric measurements
Description
Evaluation of waist circumference
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in body composition
Description
Evaluation of body composition by osteodensitometry
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in chronic inflammation
Description
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in gene expression levels
Description
Transcriptomic analyses to investigate underlying mechanisms of action
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in circulating levels of plasma metabolites
Description
Metabolomic analyses to investigate underlying mechanisms of action
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in maple-derived metabolites present in stool
Description
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
Title
Change in blood pressure
Description
Evaluation of systolic and diastolic blood pressure
Time Frame
Change between the beginning and the end of each treatment (8 weeks each)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
INAF, Université Laval
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
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Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
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