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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential benefits of a freeze-dried wild blueberry powder on heart health, brain function, and gut health in adult women with prediabetes. Participants will consume either the blueberry powder or a placebo powder daily. Women aged 45-65 with prediabetes and a Body Mass Index (BMI) between 25 and 30 may be suitable candidates for this study. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research on natural health solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating wild blueberries is generally safe for most people. Consuming freeze-dried blueberries or blueberry powder has not been linked to any major side effects. Studies indicate that blueberries are often used to help with various health issues, with no significant reports of harmful effects. Therefore, the treatment in this trial, involving freeze-dried wild blueberry powder, is expected to be well-tolerated based on the available evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prediabetes, which typically focus on lifestyle changes and medications like Metformin to improve insulin sensitivity, the treatment under study is derived from wild blueberries. Researchers are excited about this because wild blueberries contain high levels of polyphenols, particularly anthocyanins, which are believed to have powerful antioxidant and anti-inflammatory effects. These natural compounds could offer a new dietary approach to managing blood sugar levels, potentially providing a safe and tasty alternative or complement to existing therapies.

What evidence suggests that wild blueberry might be an effective treatment for prediabetes?

This trial will compare the effects of wild blueberry powder with a placebo in individuals with prediabetes. Research has shown that wild blueberry powder can benefit health in ways important for people with prediabetes. Previous studies found that eating blueberries can improve blood vessel function and increase levels of HDL-cholesterol, the "good" cholesterol. Research on mice showed that blueberry powder can help the body manage blood sugar levels better. Additionally, studies suggest that eating blueberries might reduce the risk of developing type 2 diabetes. These findings indicate that wild blueberries may aid blood sugar control and overall health in people with prediabetes. ^{2 6 7 8 9}

Who Is on the Research Team?

Rafaela G Feresin, PhD

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

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

I have a history of cancer or certain chronic conditions.

Smoking

Allergies to berries

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8389043/

Blueberry as an Attractive Functional Fruit to Prevent (Pre) ... Improved markers of vascular function and elements of lipid status (increased HDL-cholesterol and alipoprotein A-I) were detected following 1 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322002538

Recent Research on the Health Benefits of Blueberries and ... Obese hyperglycemic mice that consumed blueberry powder that was sorbed and concentrated on defatted soybean flour had improved oral glucose tolerance and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06735651

Wild Blueberries for Gut, Brain, and Cardiometabolic ... ... wild blueberry powder improves gut, cardiometabolic, and cognitive function in women with prediabetes. Investigators hypothesize that daily consumption of wild ...

4. mdpi.com mdpi.com/2072-6643/15/9/2031

Vaccinium as Potential Therapy for Diabetes and ... Mice treated with bilberry extract (BBE) show a considerable reduction in blood glucose levels [102]. One study showed that rats treated with bilberry extract ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5187542/

Blueberries' Impact on Insulin Resistance and Glucose ... Epidemiological evidence indicates that incorporating blueberries into the diet may lower the risk of developing type 2 diabetes (T2DM).

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

Blueberry - Uses, Side Effects, and More Eating freeze-dried blueberries or taking blueberry powder by mouth doesn't lower blood pressure in people with high blood pressure or other heart disease risk ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-202/bilberry

Bilberry - Uses, Side Effects, and More Bilberry is a plant used medicinally, with dried fruit and leaves. It may help reduce swelling, but there is no good evidence for night vision.

8. rxlist.com rxlist.com/supplements/blueberry.htm

Blueberry: Health Benefits, Side Effects, Uses, Dose & ... Blueberry is used for preventing cataracts, glaucoma, and treating ulcers, UTIs, MS, and more. It may help with bladder infections and contains vitamin C and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991821002333

Review Phytochemical and pharmacological anti-diabetic ... Bilberries are rich in anthocyanins, believed to have anti-diabetic properties, and have been used to improve glycemic control, with a hypoglycemic effect.