Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

NCT ID: NCT03620617

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

2018-01-08

Study Completion Date

2027-12-31

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 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.

Detailed Description

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Conditions

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Gut Microbiota Metabolic Syndrome

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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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).

Group Type EXPERIMENTAL

Raspberry supplement

Intervention Type DIETARY_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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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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.

Reference Type DERIVED
PMID: 35016998 (View on PubMed)

Other Identifiers

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RAMI 2017-218

Identifier Type: -

Identifier Source: org_study_id

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