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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blueberry powder can improve gut health and potentially prevent metabolic syndrome, a condition linked to obesity that can affect heart health. Researchers aim to determine if the natural compounds in blueberries positively impact the gut and overall health. Participants will receive either blueberry powder or a placebo (a substance with no active ingredient) to compare effects. The trial seeks men and premenopausal women who are generally healthy but have a higher body weight or waist size. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on natural health solutions.

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.

What prior data suggests that blueberry powder is safe for human consumption?

Research shows that blueberry powder is generally safe for most people. In previous studies, some individuals experienced minor side effects such as constipation, diarrhea, nausea, or vomiting when using freeze-dried blueberries. However, not everyone encounters these side effects.

Other studies have explored blueberry powder's potential benefits for metabolic syndrome, which relates to obesity and heart problems. These studies have not identified any serious safety issues, suggesting that blueberry powder is well-tolerated.

In summary, while a few individuals might experience minor digestive issues, research indicates that blueberry powder is mostly safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for metabolic syndrome, which often include medications like statins or antihypertensives, the blueberry powder is a natural alternative that focuses on dietary intervention. Researchers are excited about this treatment because blueberries are rich in antioxidants and bioactive compounds that may improve metabolic health. This natural approach could offer a gentler and possibly more holistic way to manage metabolic syndrome, potentially reducing the need for multiple medications and their associated side effects.

What evidence suggests that blueberry powder might be an effective treatment for metabolic syndrome?

This trial will compare the effects of blueberry powder with a placebo powder on metabolic syndrome. Research has shown that blueberries might help with metabolic syndrome, which includes issues like high blood pressure and unhealthy cholesterol levels. One study found that eating blueberries improved heart health in various groups, including those with metabolic syndrome. Another review demonstrated that blueberries positively affect blood fats and blood pressure. Additionally, freeze-dried blueberries improved heart and metabolic health in men with type 2 diabetes, a condition linked to metabolic syndrome. These findings suggest that blueberries could help manage metabolic syndrome by supporting heart and metabolic health. ^{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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130140/

An 8-week freeze-dried blueberry supplement impacts ... The objective was to examine the effects of blueberry supplement consumption on metabolic syndrome (MetS) parameters and potential underlying mechanisms of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06735651

Study Details | NCT06735651 | Wild Blueberries for Gut, ... We and others have shown that blueberry intake improves heart health in healthy men, hypertensive postmenopausal women, and men and women with metabolic ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531721000208

Blueberry intervention improves metabolic syndrome risk ... The meta-analysis showed that blueberry may be efficacious in the treatment of MetS, due to its beneficial effects on lipid and blood pressure markers.

4. jn.nutrition.org jn.nutrition.org/article/S0022-3166(25)00437-7/abstract

Blueberry Bioactives in Metabolic Syndrome This review provides an in-depth analysis of the bioactive components of blueberries and their roles in mitigating various aspects of MetS, including ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7170047/

Effect of Blueberry Consumption on Cardiometabolic Health ... Consumption of 22 g freeze-dried blueberries for 8 wk may beneficially affect cardiometabolic health parameters in men with type 2 diabetes.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022316625004377

Blueberry Bioactives in Metabolic Syndrome Moreover, by consuming 50 g of dried blueberry powder daily for 8 weeks, individuals at risk of MetS exhibit significant accumulation of taurodeoxycholic acid, ...

7. mdpi.com mdpi.com/2072-6643/14/13/2562

Effects of Blueberry Consumption on Cardiovascular ... The current study assessed the effects of whole blueberry and freeze-dried blueberry powder compared to a control on cardiovascular health in young adults.

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1013/blueberry

Blueberry - Uses, Side Effects, and More Drinks made with freeze-dried blueberries might cause constipation, diarrhea, nausea, or vomiting in some people. There isn't enough reliable information to ...