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

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT03754504
Collaborator
Naturex (Other)
24
1
2
16.5
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Cranberry powder
  • Dietary Supplement: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 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 :
Oct 15, 2018
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Gut Microbiota Diversity [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 [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 [At the beginning and the end of each treatment (4 weeks each)]

    Plasma zonulin

  3. Change in Inflammation state of the tissue [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 [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 [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 [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 [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 [At the beginning and the end of each treatment (4 weeks each)]

    Evaluation of plasma fasting glucose and insulin concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut sur la nutrition et les aliments fonctionnels Québec Canada G1V 0A6

Sponsors and Collaborators

  • Laval University
  • Naturex

Investigators

  • Principal Investigator: André Marette, Ph.D, Institute of nutrition and functional foods, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
André Marette, Professor, Laval University
ClinicalTrials.gov Identifier:
NCT03754504
Other Study ID Numbers:
  • MICA 2018-146
First Posted:
Nov 27, 2018
Last Update Posted:
Mar 30, 2020
Last Verified:
Mar 1, 2020
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:

Study Results

No Results Posted as of Mar 30, 2020