Institute of nutrition and functional foods, Laval University
Québec, Quebec, G1V 0A6, Canada
NCT Number: NCT03800277
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 0A6, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supplementation of polyphenols from cranberry extract
Supplementation of inulin from Agaves powder
Supplementation with placebo
Time frame: At the beginning and the end of treatment (10 weeks)
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)
effect of the supplements on plasma concentration of zonulin
Time frame: At the beginning and the end of treatment (10 weeks)
effect of the supplements on fecal calprotectin and lactoferrin
Time frame: At the beginning and the end of treatment (10 weeks)
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)
effect of the supplements on serum concentration of glucose
Time frame: At the beginning and the end of treatment (10 weeks)
effect of the supplements on serum concentration of insulin and C-peptide
Time frame: At the beginning and the end of treatment (10 weeks)
Global variation of the fecal microbiota and gut microbiota profiling
Laval University
Other
Prebiotic Supplementation and Metabolic Endotoxemia and Modulation of the Gut Microbiota: Double-blind and Randomized Parallel Clinical Study of the Efficacy and Synergistical Effect of Cranberry Polyphenols and Inulin From Agaves
Acronym: Phenulin
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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