Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

NCT03266055 | Active Not Recruiting

• 1 other identifier: BLEUET 2017-135
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Microbiota; Metabolic Syndrome

Keywords

Blueberry; Diet

Outcome Measures

Primary Outcomes (2)

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

  12 months

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

  12 months

Secondary Outcomes (6)

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

  3-6 months

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

  3-6 months

• Changes in the gut microbiota composition in overweight/obese men and women taking either blueberry powder or placebo blueberry powder

  3-6 months

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

  12 months

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

  12 months

Study Arms (2)

Blueberry powder

EXPERIMENTAL

Dietary Supplement: 50 g of blueberry powder, taken daily for 8 weeks

Blueberry placebo powder

PLACEBO COMPARATOR

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

Interventions

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.

Blueberry powder

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).

Blueberry placebo powder

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Laval University

Québec, G1V0A6, Canada

Location

Related Publications (1)

• Rousseau M, Horne J, Guenard F, de Toro-Martin J, Garneau V, Guay V, Kearney M, Pilon G, Roy D, Couture P, Couillard C, Marette A, Vohl MC. An 8-week freeze-dried blueberry supplement impacts immune-related pathways: a randomized, double-blind placebo-controlled trial. Genes Nutr. 2021 May 17;16(1):7. doi: 10.1186/s12263-021-00688-2.

  PMID: 34000994 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie-Claude Vohl

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: August 29, 2017
• Study Start: September 1, 2017
• Primary Completion: January 14, 2019
• Study Completion: December 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CA (1)