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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03620617
Other study ID # RAMI 2017-218
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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