Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

Not Applicable

Active, not recruiting

• Conditions: Metabolic Syndrome; Gut Microbiota
• Interventions: Dietary Supplement: 50 g of blueberry powder, taken daily for 8 weeks; Dietary Supplement: 50g of placebo blueberry powder, taken daily for 8 weeks

• Registration Number: NCT03266055
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Study Start: 2017-09-01
• Primary Completion: 2019-01-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blueberry powder	50 g of blueberry powder, taken daily for 8 weeks	-
Blueberry placebo powder	50g of placebo blueberry powder, taken daily for 8 weeks	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in blood pressure of overweight/obese men and women taking either blueberry powder or placebo blueberry powder	12 months
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 inflammation biomarkers 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
Changes in the gut microbiota composition in overweight/obese men and women taking either blueberry powder or placebo blueberry powder	3-6 months

Trial Locations

Locations (1)

Laval University; 🇨🇦 Québec, Canada