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Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

Primary Purpose

Gut Microbiota, Metabolic Syndrome

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Raspberry supplement
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gut Microbiota focused on measuring Raspberry, Diet

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laval University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Raspberry supplementation

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Changes in metabolites concentration in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Changes in the gut microbiota composition in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Changes in systolic and diastolic blood pressure of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
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).
Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

Full Information

First Posted
August 1, 2018
Last Updated
October 2, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03620617
Brief Title
Effect of Raspberry on Gut Microbiota and Metabolic Syndrome
Official Title
Beneficial Effects of Raspberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, Metabolic Syndrome
Keywords
Raspberry, Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Raspberry supplementation
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Raspberry supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Vohl
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Québec
ZIP/Postal Code
G1V0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35016998
Citation
Franck M, de Toro-Martin J, Varin TV, Garneau V, Pilon G, Roy D, Couture P, Couillard C, Marette A, Vohl MC. Raspberry consumption: identification of distinct immune-metabolic response profiles by whole blood transcriptome profiling. J Nutr Biochem. 2022 Mar;101:108946. doi: 10.1016/j.jnutbio.2022.108946. Epub 2022 Jan 10. Erratum In: J Nutr Biochem. 2022 Aug;106:109035.
Results Reference
derived

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Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

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