Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome (NCT04117802) | Clinical Trial Compass
CompletedNot Applicable
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
Canada47 participantsStarted 2019-09-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Glucose homeostasis
Timeframe: Change between the beginning and the end of each treatment (8 weeks each)