Blueberry Compounds for Healthy Eating

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Metabolic disorders, Digestive disorders, Immunologic disorders, Allergy to blueberries, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs anthocyanins, compounds found in blueberries, when consumed in different forms. Researchers aim to determine whether blueberry extract or whole blueberry powder affects the absorption and utilization of these compounds. The goal is to understand how anthocyanins might enhance health and combat disease. Healthy, non-smoking adults who can adhere to a berry-free diet during the study may be suitable candidates. As an unphased trial, this study allows participants to contribute to foundational research that could lead to new health insights.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require participants to follow a berry-restricted diet and document any accidental consumption of restricted foods.

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

Research has shown that blueberries are generally safe for most people. In studies with rats, natural chemicals from blueberries, called polyphenols, caused no harm even in large amounts. Some individuals might experience minor issues like constipation, diarrhea, nausea, or vomiting when consuming products made with freeze-dried blueberries.

No strong evidence indicates harmful effects from blueberry powder, but inhaling it might irritate the nose, throat, and lungs. Overall, blueberries are considered safe for most people, but it's always wise to observe how your body responds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on natural compounds found in blueberries, which are being explored for promoting healthy eating habits. Unlike traditional supplements or medications, these options use blueberry extract and blueberry powder, leveraging their potential nutritional benefits directly from fruit sources. This approach may offer a unique, food-based strategy to improve dietary health, potentially providing a tasty and easily integrated option for enhancing nutrition.

What evidence suggests that this trial's treatments could be effective?

Research shows that blueberries contain compounds, such as anthocyanins, which offer several health benefits. Studies have found that consuming blueberries can protect parts of the brain, improve memory, and reduce inflammation. They also help maintain gut health by strengthening the gut lining and reducing its permeability. Additionally, blueberries can aid in weight loss and reduce body fat. In this trial, participants will receive either a blueberry extract or blueberry powder confection to evaluate their effects. Blueberry extract is rich in antioxidants and may boost mood, enhance memory, and lower blood sugar levels. These findings suggest that blueberry compounds could benefit overall health and help prevent diseases. ^{4 6 7 8 9}

Who Is on the Research Team?

Yael Vodovotz

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for healthy, non-smoking adults with a BMI of 18-35 who are not pregnant, planning to conceive, or lactating. Participants must not have any metabolic, digestive or immunologic disorders and no allergies to blueberries, wheat, or soy. They should agree to avoid berries during the study and report any accidental intake.

Inclusion Criteria

I am a healthy adult living independently.

Have a body mass index (BMI) between 18 and 35 kg/m^2

Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study

Exclusion Criteria

Are strict vegans (no consumption of animal, fish or egg products)

I have taken antibiotics for a week in the past 6 months.

I am currently being treated for a condition affecting my metabolism, digestion, or immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Washout

Participants undergo a washout period to clear previous dietary influences

1 week

No visits

Treatment

Participants consume blueberry extract or powder confections and undergo metabolomic assessments

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for bioavailability and metabolite profile after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Blueberry Powder Food Product

Trial Overview The study is testing how well compounds called anthocyanins from blueberries are absorbed when consumed as part of two different confections: one made from blueberry extract and another from whole blueberry powder. The goal is to understand their impact on health and disease prevention.

How Is the Trial Designed?

Group I: Group II (blueberry powder, blueberry extract) Experimental Treatment 3 Interventions

Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Group II: Group I (blueberry extract, blueberry powder) Experimental Treatment 3 Interventions

Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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/PMC7442370/

Recent Research on the Health Benefits of Blueberries and ... Blueberry supplementation protected vulnerable brain regions, reduced deficits in spatial memory, and mitigated markers of inflammation and oxidative stress in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10538750/

Scientific Evidence for the Beneficial Effects of Dietary ... Our data analysis indicates that blueberry supplementation improves gut health by improving intestinal morphology, reducing gut permeability, suppressing ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1756464617305613

Investigation of the impact of blueberries on metabolic ... Blueberries consumed on a daily basis have been shown to significantly reduce weight loss and body fat levels in humans. •. Blueberry phenolics and antioxidants ...

4. verywellhealth.com verywellhealth.com/blueberry-extract-89424

Blueberry Extract Benefits and Precautions Blueberry extract is rich in antioxidants like quercetin and anthocyanins and may have benefits such as improving mood and memory, and lowering blood sugar.

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

Effects of Blueberry Consumption on Cardiovascular ... Plasma NO2- levels were improved by 68.66% and 4.34% separately following whole blueberry and blueberry powder supplementations compared to the baseline, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7169469/

A 90 DAY ORAL TOXICITY STUDY OF BLUEBERRY ... No adverse effects induced by purified blueberry polyphenols in rats. Proposed NOAEL of ≥ 1000 mg/kg bw/d for blueberry polyphenols in OVX rats.

7. 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 ...

8. rahrbsg.com rahrbsg.com/wp-content/uploads/2021/11/Blueberry-Fruit-Powder-SDS.pdf

SAFETY DATA SHEET may cause irritation of the nose, throat and lungs. No known significant effects or critical hazards. : Ingestion. Skin contact. : No known significant effects ...

9. rxlist.com rxlist.com/supplements/blueberry.htm

Blueberry: Health Benefits, Side Effects, Uses, Dose & ... Learn more about Blueberry health benefits, uses, side effects, effectiveness, safety, precautions, and warnings.