Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

Overview

There is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. Whether the beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. Moreover, the mechanisms of action underlying health benefits associated to blueberry consumption are still unknown. The investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of highbush blueberries can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.

Full Title of Study: “Prebiotic Effects of Blueberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 14, 2019

Interventions

  • Dietary Supplement: 50 g of blueberry powder, taken daily for 8 weeks
    • Subjects will consume blueberry powder during 8 weeks to test the possible effects of blueberries on gut microbiota composition and on metabolic syndrome parameters.
  • Dietary Supplement: 50g of placebo blueberry powder, taken daily for 8 weeks
    • Subjects will consume blueberry placebo powder to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatment (blueberry powder).

Arms, Groups and Cohorts

  • Experimental: Blueberry powder
  • Placebo Comparator: Blueberry placebo powder

Clinical Trial Outcome Measures

Primary Measures

  • Changes in plasma insulin/glucose of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 12 months
  • Changes in plasma lipids/lipoproteins of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 12 months

Secondary Measures

  • Changes in gene expression in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 3-6 months
  • Changes in metabolites concentration in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 3-6 months
  • Changes in the gut microbiota composition in overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 3-6 months
  • Changes in blood pressure of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 12 months
  • Changes in intestinal integrity of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 12 months
  • Changes in inflammation biomarkers of overweight/obese men and women taking either blueberry powder or placebo blueberry powder
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Men and premenopause women in good health – Caucasians – At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥ 80 cm for women and ≥ 94 cm for men – At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L Exclusion Criteria:

  • Metabolic disorders (hypertension, diabetes, hypercholesterolemia) – Regular use of medication affecting study parameters – Use of natural health product in the last 3 months – Use of antibiotics in the last 3 months – Nicotine users – Allergy or intolerance for blueberries – Blueberry taste aversion – More than 2 alcohol drinks par day – Particular dietary habits (vegetarism, gluten-free diet, cetogenic diet…) – Weight change of more than 5% in the last 3 months – Surgery in the last 3 months or planed during the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Laval University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marie-Claude Vohl, Professor – Laval University
  • Overall Official(s)
    • Marie-Claude Vohl, Principal Investigator, Laval University

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