Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome

April 11, 2024 updated by: André Marette, Laval University

Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 0A6
        • INAF, Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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).
Experimental: Maple
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Endotoxemia
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Change between the beginning and the end of each treatment (8 weeks each)
Change in Intestinal permeability
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Plasma zonulin
Change between the beginning and the end of each treatment (8 weeks each)
Change in Inflammation state of the tissue
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Fecal calprotectin and chromogranin
Change between the beginning and the end of each treatment (8 weeks each)
Change in Short chain fatty acids in the feces
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Measure 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
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires (the gastrointestinal symptom rating scale (GSRS) and Bristol stool chart)
Change between the beginning and the end of each treatment (8 weeks each)
Change in fat accumulation in the liver
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Change between the beginning and the end of each treatment (8 weeks each)
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of glycated haemoglobin
Change between the beginning and the end of each treatment (8 weeks each)
Change in Lipid profile
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids end of two dietary treatment
Change between the beginning and the end of each treatment (8 weeks each)
Change in anthropometric measurements
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of bmi with weight and height measurements
Change between the beginning and the end of each treatment (8 weeks each)
Change in anthropometric measurements
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of waist circumference
Change between the beginning and the end of each treatment (8 weeks each)
Change in body composition
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of body composition by osteodensitometry
Change between the beginning and the end of each treatment (8 weeks each)
Change in chronic inflammation
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Change between the beginning and the end of each treatment (8 weeks each)
Change in gene expression levels
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Transcriptomic analyses to investigate underlying mechanisms of action
Change between the beginning and the end of each treatment (8 weeks each)
Change in circulating levels of plasma metabolites
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Metabolomic analyses to investigate underlying mechanisms of action
Change between the beginning and the end of each treatment (8 weeks each)
Change in maple-derived metabolites present in stool
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Change between the beginning and the end of each treatment (8 weeks each)
Change in blood pressure
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Evaluation of systolic and diastolic blood pressure
Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota Composition
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Gut microbiota composition will be evaluated by 16S rRNA amplicon sequencing (V3-V4 region)
Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota Composition
Time Frame: Change between the beginning and the end of maple syrup treatment (8 weeks)
Gut microbiota composition will also be evaluated by whole genome sequencing
Change between the beginning and the end of maple syrup treatment (8 weeks)
Change in Gut Microbiota alpha Diversity
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
To quantify bacterial alpha diversity, Shannon's reciprocal index will be calculated
Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota alpha Diversity
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
To quantify bacterial alpha diversity, Simpson's reciprocal index will be calculated
Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota beta Diversity
Time Frame: Change between the beginning and the end of each treatment (8 weeks each)
Principal component analysis (PCA) will be performed on the Aitchison distance matrix to measure beta diversity.
Change between the beginning and the end of each treatment (8 weeks each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERABLE-21793

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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