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Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome (MICA)

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ClinicalTrials.gov Identifier: NCT03754504
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Naturex
Information provided by (Responsible Party):
André Marette, Laval University

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight Insulin Resistance Microbiota Endotoxemia Metabolic Syndrome Dietary Supplement: Cranberry powder Dietary Supplement: Placebo Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Cranberry Whole Fruit Powder on Gut Microbiota Diversity, Intestinal Health and Metabolic Syndrome in Overweight Individuals: a Proof-of-concept Study
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cranberry
Whole Cranberry Powder Supplements
Dietary Supplement: Cranberry powder
3 capsules /day of whole cranberry powder (500mg/each)

Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
3 capsules/day of a placebo comparator




Primary Outcome Measures :
  1. Change in Gut Microbiota Diversity [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Global variation of the fecal microbiota


Secondary Outcome Measures :
  1. Change in Endotoxemia [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)

  2. Change in Intestinal permeability [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Plasma zonulin

  3. Change in Inflammation state of the tissue [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Fecal calprotectin and chromogranin

  4. Change in Short chain fatty acids in the feces [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Measure short chain fatty acids in the feces

  5. Change in Gut health and stool consistency [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires

  6. Change in Lipid profile [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL and Apolipoprotein B from the beginning to the end of two dietary treatment

  7. Change in chronic inflammation [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)

  8. Change in Glucose homeostasis [ Time Frame: At the beginning and the end of each treatment (4 weeks each) ]
    Evaluation of plasma fasting glucose and insulin concentration



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754504


Contacts
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Contact: Julie Marois, M.Sc 418-656-2131 ext 5764 julie.marois@fsaa.ulaval.ca

Locations
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Canada
Institut sur la nutrition et les aliments fonctionnels Recruiting
Québec, Canada, G1V 0A6
Contact: Julie Marois, M.Sc    418-656-2131 ext 5764    julie.marois@fsaa.ulaval.ca   
Principal Investigator: André Marette, PhD         
Sub-Investigator: Marie-Claude Vohl, PhD         
Sub-Investigator: Charles Couillard, PhD         
Sub-Investigator: Patrick Couture, Md, PhD         
Sponsors and Collaborators
Laval University
Naturex
Investigators
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Principal Investigator: André Marette, Ph.D Institute of nutrition and functional foods, Laval University

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Responsible Party: André Marette, Professor, Laval University
ClinicalTrials.gov Identifier: NCT03754504     History of Changes
Other Study ID Numbers: MICA 2018-146
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Overweight
Insulin Resistance
Endotoxemia
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation