Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

NCT04117802 | Completed

• 1 other identifier: ERABLE-21793
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Glucose homeostasis

  Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test

  Change between the beginning and the end of each treatment (8 weeks each)

Secondary Outcomes (21)

• Change in Endotoxemia

  Change between the beginning and the end of each treatment (8 weeks each)

• Change in Intestinal permeability

  Change between the beginning and the end of each treatment (8 weeks each)

• Change in Inflammation state of the tissue

  Change between the beginning and the end of each treatment (8 weeks each)

• Change in Short chain fatty acids in the feces

  Change between the beginning and the end of each treatment (8 weeks each)

• Change in Gut health and stool consistency

  Change between the beginning and the end of each treatment (8 weeks each)

Study Arms (2)

Maple

EXPERIMENTAL

Other: Maple syrup

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Maple syrup 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.

Maple

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

INAF, Université Laval

Québec, G1V 0A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 39163971 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: September 3, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CA (1)