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

Primary Purpose

Overweight, Insulin Resistance, Microbiota

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cranberry powder
Placebo
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institut sur la nutrition et les aliments fonctionnels

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cranberry

Placebo

Arm Description

Whole Cranberry Powder Supplements

Placebo

Outcomes

Primary Outcome Measures

Change in Gut Microbiota Diversity
Global variation of the fecal microbiota

Secondary Outcome Measures

Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Change in Intestinal permeability
Plasma zonulin
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Change in Short chain fatty acids in the feces
Measure short chain fatty acids in the feces
Change in Gut health and stool consistency
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires
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
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Change in Glucose homeostasis
Evaluation of plasma fasting glucose and insulin concentration

Full Information

First Posted
November 19, 2018
Last Updated
March 26, 2020
Sponsor
Laval University
Collaborators
Naturex
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1. Study Identification

Unique Protocol Identification Number
NCT03754504
Brief Title
Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome
Acronym
MICA
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Naturex

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Insulin Resistance, Microbiota, Endotoxemia, Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranberry
Arm Type
Experimental
Arm Description
Whole Cranberry Powder Supplements
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry powder
Intervention Description
3 capsules /day of whole cranberry powder (500mg/each)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
3 capsules/day of a placebo comparator
Primary Outcome Measure Information:
Title
Change in Gut Microbiota Diversity
Description
Global variation of the fecal microbiota
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Secondary Outcome Measure Information:
Title
Change in Endotoxemia
Description
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Intestinal permeability
Description
Plasma zonulin
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Inflammation state of the tissue
Description
Fecal calprotectin and chromogranin
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Short chain fatty acids in the feces
Description
Measure short chain fatty acids in the feces
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Gut health and stool consistency
Description
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Lipid profile
Description
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)
Title
Change in chronic inflammation
Description
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Time Frame
At the beginning and the end of each treatment (4 weeks each)
Title
Change in Glucose homeostasis
Description
Evaluation of plasma fasting glucose and insulin concentration
Time Frame
At the beginning and the end of each treatment (4 weeks each)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Marette, Ph.D
Organizational Affiliation
Institute of nutrition and functional foods, Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut sur la nutrition et les aliments fonctionnels
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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

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