Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Beneficial Effects of Raspberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03620617
• Other study ID #: RAMI 2017-218
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: September 2025
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Laval University	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma insulin/glucose of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).		12 months
Primary	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	Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).		3-6 months
Secondary	Changes in metabolites concentration in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).		3-6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).		12 months