Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

• Sponsor: Laval University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03620617
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 55.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiota; Metabolic Syndrome	Dietary Supplement: Raspberry supplement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Beneficial Effects of Raspberry in Overweight/Obese Individuals: Potential Role of the Gut Microbiota in Alleviating the Metabolic Syndrome
• Actual Study Start Date: Jan 8, 2018
• Actual Primary Completion Date: Aug 22, 2019
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Raspberry supplementation 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).	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.
No Intervention: Control 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).

Outcome Measures

Primary Outcome Measures

1. Changes in plasma insulin/glucose of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group). [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). [12 months]

Secondary Outcome Measures

1. Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group). [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). [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). [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). [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). [12 months]

6. Changes in inflammation biomarkers of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group). [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laval University	Québec		Canada	G1V0A6

Sponsors and Collaborators

• Laval University

Investigators

• Principal Investigator: Marie-Claude Vohl, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie-Claude Vohl, Professor, Laval University
• ClinicalTrials.gov Identifier: NCT03620617
• Other Study ID Numbers: RAMI 2017-218
• First Posted: Aug 8, 2018
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marie-Claude Vohl, Professor, Laval University: Raspberry; Diet
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jul 7, 2021