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Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

L

Laval University

Status

Active, not recruiting

Conditions

Gut Microbiota
Metabolic Syndrome

Treatments

Dietary Supplement: Raspberry supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT03620617
RAMI 2017-218

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 2 patient groups

Experimental: Raspberry supplementation
Experimental group
Description:
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).
Treatment:
Dietary Supplement: Raspberry supplement
Control
No Intervention group
Description:
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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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