Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03620617

Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gut Microbiota Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laval University

Québec, G1V0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 3-6 months

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

    Time frame: 3-6 months

  3. Changes in the gut microbiota composition in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

    Time frame: 3-6 months

  4. Changes in systolic and diastolic blood pressure of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

    Time frame: 12 months

  5. 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).

    Time frame: 12 months

  6. Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2027
First posted
Aug 8, 2018
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.