An interventional study of Cranberry powder and Placebo in Overweight, Insulin Resistance and Microbiota, sponsored by Laval University. Completed at 1 site in Canada. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Cranberry-enriched diets may help prevent metabolic syndrome and its associated chronic diseases by a protective effect of gut health and microbiota. It is therefore highly relevant to test the hypothesis that a whole cranberry powder supplements (which include a mixture of polyphenols, free and fiber-associated proanthocyanidins, and fruits fibers) is associated with changes on the gut health and microbiota playing a major role in alleviating inflammation and obesity-associated metabolic disorders.
Over the past decade it has become clear that the gut microbiota is a key determinant of obesity and that its perturbations by nutritional insults play a significant role in the development of metabolic complications such as insulin resistance, type 2 diabetes, cardiovascular diseases and non-alcoholic fatty liver disease. Indeed, there is growing amounts of studies that have shown that dysbiosis of the intestinal microbiota promotes obesity-linked chronic inflammation, and is causally related to diet-induced type 2 diabetes. Our group recently published that a polyphenol-rich cranberry extract exert striking effect on the gut microbiota of high-fat and high-sucrose fed mice, which was associated with prevention of diet-induced weight gain, visceral obesity, insulin resistance and hepatic steatosis. Notably, metagenomic analyses of feces of the cranberry extract-treated mice suggested that these metabolic effects were associated with a dramatic increase in the proportion of Akkermansia muciniphila, a dominant commensal bacterium in the intestinal mucus layer which has received particular attention in the last few years since its abundance is associated with improved metabolic health and beneficial responses to various interventions in both mice and humans with obesity and diabetes. Polyphenols are now recognized as potent molecules capable to protect against obesity-linked metabolic diseases and dysbiosis. Among polyphenols, there is increasing evidence supporting the beneficial impact of dietary proanthocyanidins. Cranberries being rich in proanthocyanidins, we believe that these phyto-elements could be associated to their beneficial effects. On the other hand, apart from the recognized beneficial effects of fibers on gut health, their association with high molecular proanthocyanidins could also contribute to their health benefits.
The main objective of this study is to investigate in a cross-over randomized placebo-controlled clinical trial the beneficial properties of a whole cranberry powder on gut microbiota, intestinal health and metabolic syndrome parameters in overweight men.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's enrollment of 24 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Whole Cranberry Powder Supplements
Dietary Supplement: Cranberry powder
Placebo
Dietary Supplement: Placebo
3 capsules /day of whole cranberry powder (500mg/each)
3 capsules/day of a placebo comparator
Change in Gut Microbiota Diversity
Global variation of the fecal microbiota
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Intestinal permeability
Plasma zonulin
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Short chain fatty acids in the feces
Measure short chain fatty acids in the feces
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Gut health and stool consistency
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL and Apolipoprotein B from the beginning to the end of two dietary treatment
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Glucose homeostasis
Evaluation of plasma fasting glucose and insulin concentration
Time frame: At the beginning and the end of each treatment (4 weeks each)
Ran from Oct 2018 to primary completion in Mar 2020, 16 months.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 16 months is below that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cranberry