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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03754504
Other study ID # MICA 2018-146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date March 1, 2020

Study information

Verified date March 2020
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- overweight

- fasting insulin > 42 pmol/L

- non smoking

- Stable weight in the past 3 months

Exclusion Criteria:

- chronic diseases

- Taking drugs that could affect glucose or lipid metabolism

- Taking anti-inflammatory, immunosuppressant or anticoagulant drugs

- Inflammatory bowel disease

- vegetarians, vegan or following any restrictive dietary pattern or if they are big consumers of berries (>1 portion/day)

- taking pre- and probiotics

- antibiotics in the past 3 months or change in their regular medication

- Major surgery in the past 3 months

- taste aversion for cranberries or cranberry allergy or allergies to other ingredients used in the placebo

Study Design


Intervention

Dietary Supplement:
Cranberry powder
3 capsules /day of whole cranberry powder (500mg/each)
Placebo
3 capsules/day of a placebo comparator

Locations

Country Name City State
Canada Institut sur la nutrition et les aliments fonctionnels Québec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Naturex

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Gut Microbiota Diversity Global variation of the fecal microbiota At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Endotoxemia Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Intestinal permeability Plasma zonulin At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Inflammation state of the tissue Fecal calprotectin and chromogranin At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Short chain fatty acids in the feces Measure short chain fatty acids in the feces At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Gut health and stool consistency Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires At the beginning and the end of each treatment (4 weeks each)
Secondary 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 At the beginning and the end of each treatment (4 weeks each)
Secondary Change in chronic inflammation Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP) At the beginning and the end of each treatment (4 weeks each)
Secondary Change in Glucose homeostasis Evaluation of plasma fasting glucose and insulin concentration At the beginning and the end of each treatment (4 weeks each)
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