Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

NCT ID: NCT04117802

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Maple

Group Type: EXPERIMENTAL

Maple syrup

Intervention Type: OTHER

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

André Marette

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

INAF, Université Laval

Québec, , Canada

Countries

Canada

References

Morissette A, Agrinier AL, Gignac T, Ramadan L, Diop K, Marois J, Varin TV, Pilon G, Simard S, Larose E, Gagnon C, Arsenault BJ, Despres JP, Carreau AM, Vohl MC, Marette A. Substituting Refined Sugars With Maple Syrup Decreases Key Cardiometabolic Risk Factors in Individuals With Mild Metabolic Alterations: A Randomized, Double-Blind, Controlled Crossover Trial. J Nutr. 2024 Oct;154(10):2963-2975. doi: 10.1016/j.tjnut.2024.08.014. Epub 2024 Aug 18.

Reference Type: DERIVED

PMID: 39163971 (View on PubMed)

Other Identifiers

ERABLE-21793

Identifier Type: -

Identifier Source: org_study_id