Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

NCT03620617 | Active Not Recruiting

• 1 other identifier: RAMI 2017-218
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Gut Microbiota

Keywords

Raspberry; Diet

Outcome Measures

Primary Outcomes (2)

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

  12 months

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

  12 months

Secondary Outcomes (6)

• Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

  3-6 months

• Changes in metabolites concentration in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

  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).

  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).

  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).

  12 months

Study Arms (2)

Experimental: Raspberry supplementation

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

Raspberry supplement 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.

Experimental: Raspberry supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Laval University

Québec, G1V0A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 35016998 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie-Claude Vohl

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 8, 2018
• Study Start: January 8, 2018
• Primary Completion: August 22, 2019
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

CA (1)