OverweightNCT04117802
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
A study testing Maple syrup in people with Overweight and Microbiota, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Microbiota, Endotoxemia
- What is being tested?
- Maple syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight, Microbiota, Endotoxemia, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
- Being tested
- Maple syrup, Placebo
- Medical subject headings
- Overweight, Endotoxemia, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maple syrupOther
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.
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Maple | Experimental | Not described Receives: Other: Maple syrup |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose homeostasis
Evaluation of plasma glucose, insulin and c-peptide concentration using a 3-hour oral glucose tolerance test
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Secondary outcomes (21)
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Intestinal permeability
Plasma zonulin
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Short chain fatty acids in the feces
Measure short chain fatty acids in the feces
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut health and stool consistency
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires (the gastrointestinal symptom rating scale (GSRS) and Bristol stool chart)
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in fat accumulation in the liver
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Glucose homeostasis
Evaluation of glycated haemoglobin
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids end of two dietary treatment
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in anthropometric measurements
Evaluation of bmi with weight and height measurements
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in anthropometric measurements
Evaluation of waist circumference
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in body composition
Evaluation of body composition by osteodensitometry
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in gene expression levels
Transcriptomic analyses to investigate underlying mechanisms of action
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in circulating levels of plasma metabolites
Metabolomic analyses to investigate underlying mechanisms of action
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in maple-derived metabolites present in stool
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in blood pressure
Evaluation of systolic and diastolic blood pressure
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota Composition
Gut microbiota composition will be evaluated by 16S rRNA amplicon sequencing (V3-V4 region)
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota Composition
Gut microbiota composition will also be evaluated by whole genome sequencing
Measured: Change between the beginning and the end of maple syrup treatment (8 weeks)
Change in Gut Microbiota alpha Diversity
To quantify bacterial alpha diversity, Shannon's reciprocal index will be calculated
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota alpha Diversity
To quantify bacterial alpha diversity, Simpson's reciprocal index will be calculated
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Change in Gut Microbiota beta Diversity
Principal component analysis (PCA) will be performed on the Aitchison distance matrix to measure beta diversity.
Measured: Change between the beginning and the end of each treatment (8 weeks each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start3 Sep 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marette, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117802
- Sponsor's protocol ID
- ERABLE-21793
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2019
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39163971
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Free Sugar Replacement by Maple Syrup on Prevention of Metabolic Disorders Associated With Overweight in Humans : Role of Gut Microbiota
- ClinicalTrials.gov ID
- NCT04117802
- Acronym / sponsor ID
- ERABLE-21793
- Conditions
- Overweight, Microbiota, Endotoxemia, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maple | Experimental | Other: Maple syrup |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maple syrupSubstitution 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. | Other | Maple |
| PlaceboSubstitution 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). | Other | Placebo |
Primary outcome
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
21 secondary outcomes
Change in Endotoxemia
Time frame: 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)
Change in Inflammation state of the tissue
Time frame: 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)
Change in Gut health and stool consistency
Time frame: 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)
Change in Glucose homeostasis
Time frame: 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)
Change in anthropometric measurements
Time frame: 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)
Change in body composition
Time frame: 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)
Change in gene expression levels
Time frame: 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)
Change in maple-derived metabolites present in stool
Time frame: 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)
Change in Gut Microbiota Composition
Time frame: 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)
Change in Gut Microbiota alpha Diversity
Time frame: 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)
Change in Gut Microbiota beta Diversity
Time frame: Change between the beginning and the end of each treatment (8 weeks each)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 39163971Morissette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maple syrup in people with Overweight and Microbiota, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glucose homeostasis (time frame: Change between the beginning and the end of each treatment (8 weeks each)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.