Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

Sponsor

Laval University (Other)

Overall Status

Completed

CT.gov ID

NCT04117802

Collaborator

(none)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Microbiota Endotoxemia Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Insulin Resistance	Other: Maple syrup Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 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 :

Sep 3, 2019

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Change in Gut Microbiota Composition and Diversity [Change between the beginning and the end of each treatment (8 weeks each)]
Global variation of the fecal microbiota

Secondary Outcome Measures

Change in Endotoxemia [Change between the beginning and the end of each treatment (8 weeks each)]
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Change in Intestinal permeability [Change between the beginning and the end of each treatment (8 weeks each)]
Plasma zonulin
Change in Inflammation state of the tissue [Change between the beginning and the end of each treatment (8 weeks each)]
Fecal calprotectin and chromogranin
Change in Short chain fatty acids in the feces [Change between the beginning and the end of each treatment (8 weeks each)]
Measure short chain fatty acids in the feces
Change in Gut health and stool consistency [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)
Change in fat accumulation in the liver [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Change in Glucose homeostasis [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
Change in Glucose homeostasis [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of glycated haemoglobin
Change in Lipid profile [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
Change in anthropometric measurements [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of bmi with weight and height measurements
Change in anthropometric measurements [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of waist circumference
Change in body composition [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of body composition by osteodensitometry
Change in chronic inflammation [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Change in gene expression levels [Change between the beginning and the end of each treatment (8 weeks each)]
Transcriptomic analyses to investigate underlying mechanisms of action
Change in circulating levels of plasma metabolites [Change between the beginning and the end of each treatment (8 weeks each)]
Metabolomic analyses to investigate underlying mechanisms of action
Change in maple-derived metabolites present in stool [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
Change in blood pressure [Change between the beginning and the end of each treatment (8 weeks each)]
Evaluation of systolic and diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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