Blueberries for Metabolic Syndrome

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Antibiotics

Disqualifiers: Hypertension, Diabetes, Hypercholesterolemia, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

59 Participants Needed

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 blueberries 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 blueberry 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 highbush blueberries 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 participants who regularly use medication affecting study parameters, so you may need to stop taking certain medications to participate.

Is blueberry powder safe for human consumption?

Research shows that consuming blueberries, including in the form of freeze-dried blueberry powder, is generally safe for humans. Studies have not reported any significant adverse effects, and blueberries are known for their health benefits, such as improving cardiovascular health and reducing inflammation. ^{1 2 3 4 5}

How is blueberry powder treatment unique for metabolic syndrome?

Blueberry powder is unique for metabolic syndrome because it is a natural treatment that may improve inflammation and cardiovascular risk factors, such as blood pressure and cholesterol levels, due to its high polyphenol content, unlike many conventional medications. ^{1 3 5 6 7}

What data supports the effectiveness of the blueberry powder treatment for metabolic syndrome?

Research shows that blueberry supplementation can improve certain aspects of metabolic syndrome, such as lowering blood pressure and improving cholesterol levels. Additionally, blueberries may help reduce inflammation, which is a key factor in metabolic syndrome. ^{1 3 5 6 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 Caucasian men and premenopausal women in good health, with a BMI of 25-40 or waist circumference over 80 cm for women and 94 cm for men. Participants must have high triglycerides or fasting insulin levels. Exclusions include heavy drinkers, recent surgery or antibiotic use, smokers, certain medication users, metabolic disorder sufferers, blueberry allergies/intolerances, significant weight change recently, or special diets.

Inclusion Criteria

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

People of European descent.

My BMI is between 25 and 40, or my waist size meets the criteria.

Exclusion Criteria

You drink more than 2 alcoholic drinks every day.

You have used natural health products in the last 3 months.

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 receive either blueberry powder or placebo powder to assess the effects on gut microbiota and metabolic syndrome

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blueberry Powder

Trial Overview The study tests if daily consumption of either real blueberry powder or a placebo affects the gut microbiota and can help prevent obesity-related metabolic syndrome. It combines genetic material analysis (metagenomics), gene expression profiling (transcriptomics), and small molecule characterization (metabolomics) to understand how blueberries might benefit heart and metabolic health.

How Is the Trial Designed?

Group I: Blueberry powder Experimental Treatment 1 Intervention

Group II: Blueberry placebo powder Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

In a study involving 37 young adults, both whole blueberries and freeze-dried blueberry powder did not show significant differences in improving cardiovascular health compared to a control group, indicating that the form of blueberry may not matter for cardiovascular benefits.

However, both blueberry treatments improved plasma nitrite levels significantly compared to baseline, suggesting a potential positive effect on vascular function, even though other cardiovascular risk factors like blood pressure and cholesterol levels did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. Wang, Y., Gallegos, JL., Haskell-Ramsay, C., et al.[2022]

Wild blueberry powder retains a significant amount of its health-promoting anthocyanins in ice pops and refrigerated juice, with both products maintaining over 90% of their initial anthocyanin content after 8 weeks of storage.

The stability of polyphenolic compounds varies by product, with gummies showing much lower retention of anthocyanins (43-51%) compared to other formulations, likely due to gel hardening affecting extraction efficiency at lower temperatures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Polyphenolics during Storage of Products Prepared with Freeze-Dried Wild Blueberry Powder. Lavefve, L., Brownmiller, C., Howard, L., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Beneficial effects of blueberry supplementation on the components of metabolic syndrome: a systematic review and meta-analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Blueberries decrease cardiovascular risk factors in obese men and women with metabolic syndrome. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Wild blueberry (Vaccinium angustifolium) consumption improves inflammatory status in the obese Zucker rat model of the metabolic syndrome. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Berry Dietary Interventions in Metabolic Syndrome: New Insights. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Blueberry fruit valorization and valuable constituents: A review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Polyphenolics during Storage of Products Prepared with Freeze-Dried Wild Blueberry Powder. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of dietary blueberry pomace on selected metabolic factors associated with high fructose feeding in growing Sprague-Dawley rats. [2017]