An interventional study of Cranberry and Agaves in Endotoxemia, Metabolic Syndrome and Glucose Metabolism Disorders, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
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.
86 studies on the registry are indexed under Endotoxemia; 8 are open to participants now.
This study's enrollment of 122 is above the median of 30 across 75 interventional studies indexed under Endotoxemia.
Browse Endotoxemia studies →Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet)
Dietary Supplement: Cranberry · Dietary Supplement: Agaves
Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet)
Dietary Supplement: Cranberry · Dietary Supplement: Placebo
Placebo (2 capsules) + Agaves powder (1 single-dose packet)
Dietary Supplement: Agaves · Dietary Supplement: Placebo
Placebo (2 capsules) + Placebo powder (1 single-dose packet)
Dietary Supplement: Placebo
Supplementation of polyphenols from cranberry extract
Supplementation of inulin from Agaves powder
Supplementation with placebo
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
Time frame: At the beginning and the end of treatment (10 weeks)
Change in intestinal permeability: Measure concentration of zonulin in plasma
effect of the supplements on plasma concentration of zonulin
Time frame: 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
effect of the supplements on fecal calprotectin and lactoferrin
Time frame: 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)
Time frame: At the beginning and the end of treatment (10 weeks)
Change in glucose serum concentration
effect of the supplements on serum concentration of glucose
Time frame: 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
Time frame: 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
Time frame: At the beginning and the end of treatment (10 weeks)
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cranberry