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| Name | Class |
|---|---|
| Ministry of Agriculture, Fisheries and Food, Quebec | OTHER_GOV |
| Ministry of economic development, innovation and export trade, Quebec | UNKNOWN |
| Diana Food, Symrise | UNKNOWN |
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The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry and Agaves | Experimental | Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) |
|
| Cranberry and placebo | Experimental | Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) |
|
| Placebo and Agaves | Experimental | Placebo (2 capsules) + Agaves powder (1 single-dose packet) |
|
| Placebo and placebo | Placebo Comparator | Placebo (2 capsules) + Placebo powder (1 single-dose packet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranberry | Dietary Supplement | Supplementation of polyphenols from cranberry extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma | effect of the supplements on variation in plasma concentration of LPS and LBP | At the beginning and the end of treatment (10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intestinal permeability: Measure concentration of zonulin in plasma | effect of the supplements on plasma concentration of zonulin | At the beginning and the end of treatment (10 weeks) |
| Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène Jacques, PhD | Institute of nutrition and functional foods, Laval University | Principal Investigator |
| Yves Desjardins, PhD | Institute of nutrition and functional foods, Laval University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of nutrition and functional foods, Laval University | Québec | Quebec | G1V 0A6 | Canada |
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| ID | Term |
|---|---|
| D019446 | Endotoxemia |
| D024821 | Metabolic Syndrome |
| D044882 | Glucose Metabolism Disorders |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| D007239 | Infections |
| D014115 | Toxemia |
| D018746 |
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| Atrium Innovations |
| INDUSTRY |
| NutriAgaves, Mexico | UNKNOWN |
| Société des Produits Nestlé (SPN) | INDUSTRY |
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| Agaves | Dietary Supplement | Supplementation of inulin from Agaves powder |
|
| Placebo | Dietary Supplement | Supplementation with placebo |
|
effect of the supplements on fecal calprotectin and lactoferrin |
| At the beginning and the end of treatment (10 weeks) |
| Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum | effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23) | At the beginning and the end of treatment (10 weeks) |
| Change in glucose serum concentration | effect of the supplements on serum concentration of glucose | At the beginning and the end of treatment (10 weeks) |
| Change in insulin and C-peptide serum concentration | effect of the supplements on serum concentration of insulin and C-peptide | At the beginning and the end of treatment (10 weeks) |
| Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.) | Global variation of the fecal microbiota and gut microbiota profiling | At the beginning and the end of treatment (10 weeks) |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |