Clinical trial NCT03620617: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gut Microbiota
Metabolic Syndrome
Keywords: Raspberry
Diet
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in plasma insulin/glucose of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 12 months
measure: Changes in plasma lipides/lipoproteins of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 12 months
Secondary outcomes:
measure: Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 3-6 months
measure: Changes in metabolites concentration in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 3-6 months
measure: Changes in the gut microbiota composition in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 3-6 months
measure: Changes in systolic and diastolic blood pressure of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 12 months
measure: 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).
timeFrame: 12 months
measure: Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
timeFrame: 12 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: Marie-Claude Vohl
role: PRINCIPAL_INVESTIGATOR
References:
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.