Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

October 2, 2023 updated by: Marie-Claude Vohl, Laval University

Beneficial Effects of Raspberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the 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 raspberry 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 raspberry 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 raspberry can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V0A6
        • Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 raspberries
  • Raspberry 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Raspberry supplementation
Dietary Supplement: 280g of frozen raspberries, taken daily for 8 weeks. Subjects will consume frozen raspberry to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and control group (without raspberry).
Dietary supplement: Raspberry supplement
During the 8-week protocol, participants will be invited either to consume 280g of frozen raspberries daily (morning and evening). The daily dose is equivalent to 2 cups of raspberries.
No Intervention: Control
Control: follow their usual diet (control group). Subjects will follow their usual diet and not consume raspberry to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the experimental group (with raspberry).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in plasma insulin/glucose of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 12 months
12 months
Changes in plasma lipides/lipoproteins of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 3-6 months
3-6 months
Changes in metabolites concentration in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 3-6 months
3-6 months
Changes in the gut microbiota composition in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 3-6 months
3-6 months
Changes in systolic and diastolic blood pressure of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 12 months
12 months
Changes in intestinal integrity (plasma lipopolysaccharide (LPS) and LPS binding protein (LBP) will be measured) of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 12 months
12 months
Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Marie-Claude Vohl, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

August 22, 2019

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMI 2017-218

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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