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Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

L

Laval University

Status

Completed

Conditions

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

Treatments

Other: Maple syrup
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04117802
ERABLE-21793

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

47 participants in 2 patient groups, including a placebo group

Maple
Experimental group
Treatment:
Other: Maple syrup
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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