Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117802
• Other study ID #: ERABLE-21793
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2024
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotoxemia
• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Metabolic Syndrome
• Microbiota
• Non-Alcoholic Fatty Liver Disease
• Overweight
• Syndrome

Intervention

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
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).

Locations

Country	Name	City	State
Canada	INAF, Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glucose homeostasis	Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Endotoxemia	Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Intestinal permeability	Plasma zonulin	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Inflammation state of the tissue	Fecal calprotectin and chromogranin	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Short chain fatty acids in the feces	Measure short chain fatty acids in the feces	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	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 between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in fat accumulation in the liver	Evaluation of fat accumulation by magnetic resonance imaging (MRI)	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Glucose homeostasis	Evaluation of glycated haemoglobin	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	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 between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in anthropometric measurements	Evaluation of bmi with weight and height measurements	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in anthropometric measurements	Evaluation of waist circumference	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in body composition	Evaluation of body composition by osteodensitometry	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in chronic inflammation	Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in gene expression levels	Transcriptomic analyses to investigate underlying mechanisms of action	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in circulating levels of plasma metabolites	Metabolomic analyses to investigate underlying mechanisms of action	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	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 between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in blood pressure	Evaluation of systolic and diastolic blood pressure	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Gut Microbiota Composition	Gut microbiota composition will be evaluated by 16S rRNA amplicon sequencing (V3-V4 region)	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Gut Microbiota Composition	Gut microbiota composition will also be evaluated by whole genome sequencing	Change between the beginning and the end of maple syrup treatment (8 weeks)
Secondary	Change in Gut Microbiota alpha Diversity	To quantify bacterial alpha diversity, Shannon's reciprocal index will be calculated	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Gut Microbiota alpha Diversity	To quantify bacterial alpha diversity, Simpson's reciprocal index will be calculated	Change between the beginning and the end of each treatment (8 weeks each)
Secondary	Change in Gut Microbiota beta Diversity	Principal component analysis (PCA) will be performed on the Aitchison distance matrix to measure beta diversity.	Change between the beginning and the end of each treatment (8 weeks each)