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Polyphenols
Raspberry Supplement for Metabolic Syndrome
N/A
Waitlist Available
Led By Marie-Claude Vohl
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Study Summary
This trial will study the effects of raspberries on the gut microbiota and intestinal integrity to see if they can help prevent obesity-linked metabolic syndrome.
Who is the study for?
This trial is for men and premenopausal women in good health with a BMI between 25-40 or waist size over 80 cm for women and 94 cm for men, plus high triglycerides or fasting insulin. Participants must be Caucasian without significant weight change recently, no raspberry allergies/intolerances, low alcohol consumption, not on certain diets or medications that could affect the study.Check my eligibility
What is being tested?
The trial is testing if raspberry supplements can help improve gut bacteria and prevent obesity-related metabolic syndrome. It involves studying changes in participants' gut microbiota, gene expression related to metabolism (transcriptomics), and small molecules produced by cells (metabolomics) after taking the supplement.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to dietary supplements such as digestive discomfort. Since raspberries are generally considered safe to eat, severe side effects are unlikely; however individual tolerances vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 25 and 40, or my waist size meets the required measurements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in plasma insulin/glucose of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Changes in plasma lipides/lipoproteins of overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Secondary outcome measures
Changes in gene expression in overweight/obese men and women taking frozen raspberries daily or following their usual diet (control group).
Inflammation
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).
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Raspberry supplementationExperimental Treatment1 Intervention
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).
Group II: ControlActive Control1 Intervention
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).
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Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,213 Total Patients Enrolled
Marie-Claude VohlPrincipal InvestigatorLaval University
3 Previous Clinical Trials
123 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People of European descentYour triglyceride levels are higher than 1.35 mmol/L or your fasting insulin levels are higher than 42 pmol/L.You don't like the taste of raspberries.I have had surgery in the last 3 months or will have during the study.You have gained or lost more than 5% of your body weight in the last 3 months.I am a healthy man or a woman who has not gone through menopause.I have a condition like high blood pressure, diabetes, or high cholesterol.You use nicotine.You are allergic to or cannot tolerate raspberries.You drink more than two alcoholic drinks every day.My BMI is between 25 and 40, or my waist size meets the required measurements.You have specific eating habits like being a vegetarian, eating gluten-free, or following a ketogenic diet.I regularly take medication that could affect the study.I have not taken antibiotics in the last 3 months.I have used natural health products in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Experimental: Raspberry supplementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria makes someone a suitable participant for this investigation?
"To participate in the trial, applicants must have metabolic syndrome and be aged between 18 and 60. A total of 59 people are required to take part."
Answered by AI
Is enrollment for this trial still available to prospective participants?
"As of September 6th 2022, this clinical trial is no longer recruiting patients. First posted on the 8th of January 2018, it has since been closed to new participants. Nevertheless, there are still 1481 other trials seeking enrolment at present."
Answered by AI
Is this experiment open to those aged 60 and over?
"This trial is seeking the participation of adult individuals aged 18 or above, but below 60 years old."
Answered by AI
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