Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

59 Participants Needed

Raspberry Supplement for Metabolic Syndrome

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Antibiotics

Disqualifiers: Hypertension, Diabetes, Hypercholesterolemia, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial excludes people who regularly use medications that affect the study parameters, so you may need to stop taking certain medications to participate.

Is the raspberry supplement safe for humans?

Research suggests that red raspberries, which contain beneficial compounds like polyphenols, are generally safe for human consumption and may help reduce the risk of metabolic diseases. However, more high-quality human studies are needed to fully understand their safety and effects.¹ ² ³ ⁴ ⁵

How does the raspberry supplement treatment for metabolic syndrome differ from other treatments?

The raspberry supplement is unique because it contains bioactive compounds like ellagitannins and anthocyanins, which have antioxidant and anti-inflammatory effects. These compounds may help reduce the risk of metabolic diseases by targeting oxidative stress and inflammation, offering a natural alternative to traditional pharmacotherapy.¹ ² ³ ⁵ ⁶

What data supports the effectiveness of the raspberry supplement treatment for metabolic syndrome?

Research suggests that berries, including raspberries, may help with metabolic syndrome by improving cholesterol levels and reducing inflammation, thanks to their antioxidant compounds like anthocyanins. While specific studies on raspberries are limited, similar berries have shown benefits in managing risk factors associated with metabolic syndrome.¹ ² ³ ⁷ ⁸

Who Is on the Research Team?

Marie-Claude Vohl

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

People of European descent

Your triglyceride levels are higher than 1.35 mmol/L or your fasting insulin levels are higher than 42 pmol/L.

I am a healthy man or a woman who has not gone through menopause.

See 1 more

Exclusion Criteria

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.

See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group consume 280g of frozen raspberries daily for 8 weeks, while the control group follows their usual diet without raspberry supplementation

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on changes in gut microbiota composition and metabolic syndrome parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

Raspberry supplement

Trial Overview 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.

How Is the Trial Designed?

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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

Increased intake of berries high in anthocyanins, particularly freeze-dried strawberries, is associated with a significant reduction in low-density lipoprotein (LDL) levels, which is beneficial for cardiovascular health.

The consumption of cranberries and freeze-dried berries also led to increases in high-density lipoprotein (HDL) levels during 4-6 week interventions, suggesting a positive impact on metabolic syndrome risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Anthocyanin-rich Berries on the Risk of Metabolic Syndrome: A Systematic Review and Meta-analysis.Wilken, MR., Lambert, MNT., Christensen, CB., et al.[2022]