Blueberries for Prediabetes

Overseen By Tricia Z King, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgia State University

Must not be taking: Insulin, Antidiabetics, Antibiotics, Anti-inflammatories

Disqualifiers: Allergies to berries, Cancer, Hypertension, Smoking, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Will I have to stop taking my current medications?

If you are using insulin, antidiabetic, antibiotics, or anti-inflammatory drugs, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment involving wild blueberry and bilberry powders for prediabetes?

Research suggests that bilberries and blueberries, which are rich in anthocyanins (natural compounds found in berries), may help lower the risk of developing type 2 diabetes and improve related health issues. Additionally, bilberry has shown potential antidiabetic effects in traditional medicine and animal studies. ^{1 2 3 4 5}

Is it safe to use blueberries or bilberries for prediabetes?

Blueberries and bilberries have been used traditionally for their health benefits, and studies suggest they may help with diabetes and heart health. However, specific clinical trials on their safety for prediabetes are lacking, so it's best to consult with a healthcare provider before starting any new treatment. ^{1 2 3 5 6}

How is the blueberry treatment for prediabetes unique?

The blueberry treatment for prediabetes is unique because it uses wild blueberry powder, which contains high levels of procyanidin type A trimers, known for their antidiabetic properties. This natural approach may help regulate blood sugar levels by inhibiting enzymes that break down carbohydrates, offering a novel alternative to traditional medications. ^{1 3 6 7 8}

Research Team

Rafaela G Feresin, PhD

Principal Investigator

Georgia State University

Eligibility Criteria

This trial is for adult women who are overweight or have prediabetes, which means they're at risk of developing diabetes due to high blood sugar levels. They should not be currently pregnant and must be experiencing some insulin resistance or glucose intolerance.

Inclusion Criteria

Body Mass Index between 25-30 kg/m^2

Prediabetes (fasting blood glucose 100-125 mg/dL and/or HbA1c percentage between 5.7-6.4)

I am a woman aged between 45 and 65.

Exclusion Criteria

Allergies to berries

I am currently in a weight loss program.

I am currently taking insulin, antidiabetic, antibiotics, or anti-inflammatory drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily consumption of 22 g of freeze-dried blueberry powder or placebo for 6 weeks

6 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Wild Blueberry

Trial Overview The study is testing whether a freeze-dried wild blueberry powder can improve heart health, brain function, and the balance of bacteria in the gut compared to a placebo (a substance with no therapeutic effect).

Participant Groups

Group I: Wild Blueberry Experimental Treatment 1 Intervention

22 g of freeze-dried wild blueberry freeze-dried powder per day

Group II: Placebo Placebo Group 1 Intervention

22 g of freeze-dried macronutrient-matched placebo powder per day

Wild Blueberry is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Wild Blueberry Powder for:

• General health supplement
• Heavy metal detox

Approved in United States as Wild Blueberry Powder for:

• General health supplement
• Cardiometabolic health support

Approved in Canada as Wild Blueberry Powder for:

• General health supplement
• Antioxidant support

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Wild Blueberry Association of North America

Collaborator

Trials

3

Recruited

100+

Wild Blueberry Association of North America

Collaborator

Trials

7

Recruited

340+

Findings from Research

The study found that the stems of wild bilberry (Vaccinium myrtillus) contain significantly higher levels of procyanidin type A trimers, a known antidiabetic compound, compared to the leaves, with concentrations up to 100 times greater.

Geographical and seasonal variations can greatly affect the active compound levels in bilberry plants, suggesting that the stems of V. myrtillus should be prioritized for future research on diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of procyanidin type A- and -B trimers content in aerial parts of some Vaccinium species and cultivars. Toomik, P., Püssa, T., Raal, A.[2014]

Epidemiological studies suggest that higher consumption of anthocyanins, particularly from berries like bilberries and blueberries, may lower the risk of cardiovascular disease and type 2 diabetes, indicating a potential protective effect.

While animal and in vitro studies show promising results for the anti-diabetic properties of these berries, there is a need for more clinical trials to confirm their efficacy and explore their use as nutraceuticals in diabetes prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Review of Blue- and Bilberries' Potential to Curb Cardio-Metabolic Perturbations: Focus on Diabetes. Crespo, MC., Visioli, F.[2018]

Fermented blueberry extract (FBE/F1) significantly reduces triglyceride accumulation in fat cells by up to 75%, indicating its potential as an anti-obesity treatment.

Key bioactive compounds, such as catechol and chlorogenic acid, also show strong anti-adipogenic effects, suggesting that fermented blueberries could be developed into nutraceuticals for managing obesity and Type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented blueberry juice extract and its specific fractions have an anti-adipogenic effect in 3 T3-L1 cells. Sánchez-Villavicencio, ML., Vinqvist-Tymchuk, M., Kalt, W., et al.[2018]

In a study involving patients with pre-diabetes, a nutraceutical compound containing Ilex paraguariensis, White Mulberry, and Chromium Picolinate significantly reduced fasting plasma glucose (FPG) by 7.8% and improved insulin resistance, with 67% of patients achieving normal insulin sensitivity after 3 months.

The treatment also led to a notable decrease in triglyceride levels by 8.3%, and 16.6% of patients returned to normal glycemic status, indicating the potential efficacy of this nutraceutical in managing pre-diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ilex paraguariensis, white mulberry and chromium picolinate in patients with pre-diabetes. Derosa, G., D'Angelo, A., Maffioli, P.[2020]

Bilberry supplementation significantly reduced blood glucose levels and improved insulin levels in diabetic rats, outperforming the positive control treatment with glibenclamide over a 4-week period.

Bilberry not only lowered total cholesterol and triglyceride levels but also prevented the decline of beneficial HDL cholesterol, suggesting it may help protect against cardiovascular risks associated with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-hyperglycemic and anti-hyperlipidemic effects of Vaccinium myrtillus fruit in experimentally induced diabetes (antidiabetic effect of Vaccinium myrtillus fruit). Asgary, S., RafieianKopaei, M., Sahebkar, A., et al.[2016]

Polyphenol-rich extracts from bilberries (Vaccinium myrtillus L.) have shown significant inhibitory effects on the enzyme α-glucosidase, which is important for managing blood sugar levels in type 2 diabetes, with effective concentrations identified at 20 μg GAE/ml for methanol extracts.

The study found that bilberries contain high levels of phenolic compounds, such as gallic acid and chlorogenic acid, which contribute to their potential health benefits, including antioxidant and anti-inflammatory properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Extracts of Bilberries (Vaccinium myrtillus L.) on Amyloglucosidase and α-Glucosidase Activity. Karcheva-Bahchevanska, DP., Lukova, PK., Nikolova, MM., et al.[2020]

A fermented oat meal drink containing bilberries resulted in a significantly lower insulin response compared to the expected response based on its glycaemic impact, suggesting a potential benefit for blood sugar regulation.

The study indicates that bilberries may contain bioactive components that contribute to this reduced insulin demand, although the exact mechanism remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bilberry drink with fermented oatmeal decreases postprandial insulin demand in young healthy adults. Granfeldt, YE., Björck, IM.[2021]

Blueberry extracts significantly increase the expression of GLUT-2 and PPARγ in liver cells, which are important for glucose transport and metabolism, indicating a potential hypoglycemic effect.

The hypoglycemic activity of blueberry may be attributed to the synergistic effects of its major components, including caffeoylquinic acid derivatives and quercetin glycosides, while also inhibiting inflammatory pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemic activity and constituents analysis of blueberry (Vaccinium corymbosum) fruit extracts. Huang, W., Yao, L., He, X., et al.[2022]

References

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

Variability of procyanidin type A- and -B trimers content in aerial parts of some Vaccinium species and cultivars. [2014]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A Brief Review of Blue- and Bilberries' Potential to Curb Cardio-Metabolic Perturbations: Focus on Diabetes. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Fermented blueberry juice extract and its specific fractions have an anti-adipogenic effect in 3 T3-L1 cells. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Ilex paraguariensis, white mulberry and chromium picolinate in patients with pre-diabetes. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Anti-hyperglycemic and anti-hyperlipidemic effects of Vaccinium myrtillus fruit in experimentally induced diabetes (antidiabetic effect of Vaccinium myrtillus fruit). [2016]

6. Bulgaria pubmed.ncbi.nlm.nih.gov

Effect of Extracts of Bilberries (Vaccinium myrtillus L.) on Amyloglucosidase and α-Glucosidase Activity. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A bilberry drink with fermented oatmeal decreases postprandial insulin demand in young healthy adults. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Hypoglycemic activity and constituents analysis of blueberry (Vaccinium corymbosum) fruit extracts. [2022]