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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how raspberry supplements might improve gut health and reduce issues related to metabolic syndrome, such as obesity. Researchers aim to determine if the benefits of raspberries can affect gut bacteria and enhance overall metabolic health. Participants will be divided into two groups: one will maintain their usual diet, while the other will add raspberry supplements daily for eight weeks. Ideal candidates are healthy Caucasian men and premenopausal women with a waist circumference meeting specific measurements or certain blood markers related to metabolism.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on natural supplements and metabolic health.

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 there any evidence suggesting that the raspberry supplement is likely to be safe for humans?

Research shows that raspberry supplements are likely safe for people. Since 1965, raspberry ketone, a substance in raspberries, has been considered safe for use in food, drugs, or cosmetics, indicating it is generally well-tolerated.

Other studies have found that eating raspberries can help lower insulin levels and reduce inflammation, with no major safety issues reported. However, there is insufficient information about the long-term safety of using raspberry ketone as a medicine.

In summary, while eating raspberries is usually safe, more research is needed to understand the long-term effects of raspberry supplements on health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using raspberry supplements for metabolic syndrome because they offer a natural and potentially safer alternative to traditional medications like metformin or statins. Unlike these standard treatments, raspberries are rich in antioxidants and fiber, which might improve gut health and metabolic parameters without the side effects often associated with pharmaceuticals. Additionally, the daily consumption of whole raspberries could provide a more holistic approach, addressing multiple aspects of metabolic health simultaneously.

What evidence suggests that raspberry supplementation might be an effective treatment for metabolic syndrome?

This trial will compare the effects of raspberry supplementation with a control group. Research has shown that consuming raspberries may benefit metabolism. Studies suggest that raspberries can help the body manage sugar and insulin, which is important for conditions like metabolic syndrome. Evidence indicates that raspberries might lower certain inflammation markers, such as TNF-α, a protein that can cause inflammation. Additionally, raspberries may positively affect gut bacteria, potentially preventing obesity-related health problems. While some studies have not found changes in body size or liver health, the potential benefits for metabolism and gut health remain promising. ^{1 3 6 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.

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.

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?

Group I: Experimental: Raspberry supplementation Experimental Treatment 1 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: Control Active Control 1 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).

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11163149/

The Effects of Raspberry Consumption on Glycemic ...

This review revealed that raspberry consumption led to a significant increase and decrease in insulin and TNF-α concentrations, respectively.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7767072/

Effects of Daily Raspberry Consumption on Immune ...

Consumption of red raspberries has been reported to exert acute beneficial effects on postprandial glycemia, insulinemia, triglyceridemia, and ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03620617

Effect of Raspberry on Gut Microbiota and Metabolic ...

A prebiotic activity of raspberry can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.

4.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1419417/full

The effects of raspberry consumption on anthropometric ...

This review revealed that raspberry consumption had no significant impact on anthropometric indices or liver function tests.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0924224425002420

Harnessing the bioactive properties of red raspberries for ...

The intake of red raspberries may play a vital role in mitigating the risk factors associated with MetS by targeting key drivers of metabolic dysfunction, such ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352364615300493

Further research on the biological activities and the safety ...

Raspberry ketone has held GRAS (Generally Recognized as Safe; 21CFR172.515) status since 1965 [1] as an ingredient for use in a food, drug, or cosmetic and is ...

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1262/raspberry-ketone

Raspberry Ketone - Uses, Side Effects, and More

When used as medicine, there isn't enough reliable information to know if raspberry ketone is safe. It is chemically related to a stimulant called ...

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/fsn3.3940

The effects of raspberry consumption on lipid profile and ...

A significant reducing effect of raspberry consumption on total cholesterol levels in participants with metabolic syndrome, borderline-high cholesterol, ...