Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

Sponsor

Laval University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03266055

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiota Metabolic Syndrome	Dietary Supplement: 50 g of blueberry powder, taken daily for 8 weeks Dietary Supplement: 50g of placebo blueberry powder, taken daily for 8 weeks	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Jan 14, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blueberry powder	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.
Placebo Comparator: Blueberry placebo powder	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).

Arm

Intervention/Treatment

Experimental: Blueberry powder

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.

Placebo Comparator: Blueberry placebo powder

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).

Outcome Measures

Primary Outcome Measures

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

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]
Changes in inflammation biomarkers of overweight/obese men and women taking either blueberry powder or placebo blueberry powder [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laval University	Québec		Canada	G1V0A6

Sponsors and Collaborators

Laval University

Investigators

Principal Investigator: Marie-Claude Vohl, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marie-Claude Vohl, Professor, Laval University

ClinicalTrials.gov Identifier:

NCT03266055

Other Study ID Numbers:

BLEUET 2017-135

First Posted:

Aug 29, 2017

Last Update Posted:

Jul 7, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marie-Claude Vohl, Professor, Laval University

Blueberry

Diet

Additional relevant MeSH terms:

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Jul 7, 2021