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NCT Number: NCT03266055

Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gut Microbiota Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laval University

Québec, G1V0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50 g of blueberry powder, taken daily for 8 weeks

Dietary Supplement

Subjects will consume blueberry powder during 8 weeks to test the possible effects of blueberries on gut microbiota composition and on metabolic syndrome parameters.

50g of placebo blueberry powder, taken daily for 8 weeks

Dietary Supplement

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).

Primary outcomes

  1. Changes in plasma insulin/glucose of overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 12 months

  2. Changes in plasma lipids/lipoproteins of overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 12 months

Secondary outcomes

  1. Changes in gene expression in overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 3-6 months

  2. Changes in metabolites concentration in overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 3-6 months

  3. 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

  4. Changes in blood pressure of overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 12 months

  5. Changes in intestinal integrity of overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 12 months

  6. Changes in inflammation biomarkers of overweight/obese men and women taking either blueberry powder or placebo blueberry powder

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Prebiotic Effects of Blueberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome.

Important dates

Study start
2017
Primary completion
2019
Study completion
2025
First posted
Aug 29, 2017
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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