Clinical trial NCT04117802: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Microbiota
Endotoxemia
Metabolic Syndrome
Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Glucose homeostasis
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
Secondary outcomes:
measure: Change in Endotoxemia
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Intestinal permeability
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Inflammation state of the tissue
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Short chain fatty acids in the feces
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Gut health and stool consistency
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in fat accumulation in the liver
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Glucose homeostasis
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Lipid profile
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in anthropometric measurements
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in anthropometric measurements
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in body composition
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in chronic inflammation
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in gene expression levels
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in circulating levels of plasma metabolites
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in maple-derived metabolites present in stool
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in blood pressure
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Gut Microbiota Composition
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Gut Microbiota Composition
timeFrame: Change between the beginning and the end of maple syrup treatment (8 weeks)
measure: Change in Gut Microbiota alpha Diversity
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Gut Microbiota alpha Diversity
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
measure: Change in Gut Microbiota beta Diversity
timeFrame: Change between the beginning and the end of each treatment (8 weeks each)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: INAF, Université Laval
Study officials:
References: