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Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

NCT ID: NCT03266055

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gut Microbiota Metabolic Syndrome

Keywords

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Blueberry Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Blueberry powder

Group Type EXPERIMENTAL

50 g of blueberry powder, taken daily for 8 weeks

Intervention Type 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 placebo powder

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Marie-Claude Vohl

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-Claude Vohl

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval University

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34000994 (View on PubMed)

Other Identifiers

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BLEUET 2017-135

Identifier Type: -

Identifier Source: org_study_id