Strawberry Powder for Insulin Sensitivity

(STRW Trial)

Overseen By Indika Edirisinghe, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Must not be taking: Antioxidants, Anti-inflammatories, Lipid-lowering, Blood pressure-lowering

Disqualifiers: Vascular disease, Cancer, Gastrointestinal issues, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how strawberry powder might improve insulin sensitivity and reduce inflammation, both crucial for managing blood sugar and supporting vascular health. Participants will test different doses of freeze-dried whole strawberry powder to determine its effect on insulin response and inflammation levels. The study seeks individuals with low-grade inflammation, indicated by specific blood markers, who are not taking medication that could influence the results. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on natural health solutions.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications, especially those that could interfere with the study, like anti-inflammatory drugs or lipid-lowering medications. If you're taking dietary supplements, you might need a 30-day period without them before starting the trial.

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

Research shows that freeze-dried strawberry powder is generally safe and easy to tolerate. Studies have examined different amounts to improve insulin use, which is crucial for controlling blood sugar. For example, one study found that consuming 40 grams of freeze-dried strawberry powder with meals helped manage insulin levels over six hours. Another study demonstrated that strawberries could enhance the body's insulin use.

So far, these studies have not reported major negative effects from consuming freeze-dried strawberry powder. It has not been known to cause serious side effects, making it a safe option based on current research. However, participants should consider any personal allergies or sensitivities to strawberries before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using freeze-dried whole strawberry powder to improve insulin sensitivity because it offers a natural alternative to traditional medications typically used to manage insulin resistance, like metformin. Unlike these standard treatments, strawberry powder is derived from a whole food source, which may have fewer side effects and be more appealing to those seeking natural remedies. Additionally, strawberries are rich in bioactive compounds like anthocyanins, which could enhance insulin sensitivity in a way that's both gentle and effective. The trial explores both high (36g) and low (12g) doses, which could help determine the optimal amount needed for benefits without overconsumption.

What evidence suggests that this trial's treatments could be effective for improving insulin sensitivity?

Research has shown that freeze-dried strawberry powder might improve the body's insulin use. In one study, participants who consumed 40 grams of this powder with a high-carb meal had lower insulin levels over six hours. Another study found that daily strawberry consumption for 12 weeks improved prediabetes and heart health. Evidence also suggests that strawberries can aid when the body struggles with insulin use and can reduce inflammation, the body's response to injury or infection. These findings indicate that strawberries could help manage insulin sensitivity issues. Participants in this trial will receive either a high dose (36g), a low dose (12g), or no strawberry powder to assess its effects on insulin sensitivity. ^{1 2 3 6 7}

Who Is on the Research Team?

Britt Burton-Freeman, Ph.D

Principal Investigator

Illinois Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes who may have insulin sensitivity issues, inflammation, or are at risk of developing diabetes. Participants should not have any allergies to strawberries and must be willing to consume strawberry powder or a control powder daily.

Inclusion Criteria

BMI ≥ 25 kg/m2

Men or women 20-60 years of age

High sensitivity C-Reactive Protein (hs-CRP) >1.0 and ≤10 ng/L

Exclusion Criteria

Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI

Participation in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month

Vegan or other extreme dietary regimens as judged by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying doses of strawberry intake (1 cup or 3 cup FWeq) or control (0 cup) to study effects on inflammation, oxidative stress, and insulin sensitivity

4 weeks

Weekly visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in inflammation and insulin sensitivity

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Freeze-dried whole strawberry powder

Trial Overview The study tests the effects of different doses of freeze-dried whole strawberry powder (12g and 36g) versus a control (0g), on immune and vascular health over four weeks. It measures how strawberries might improve inflammation markers, blood sugar regulation, and oxidative stress defense.

How Is the Trial Designed?

Group I: 36g of strawberry Experimental Treatment 1 Intervention

High dose intervention

Group II: 12g of strawberry Experimental Treatment 1 Intervention

Low dose intervention

Group III: 0g of strawberry Placebo Group 1 Intervention

Control

Who Is Running the Clinical Trial?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials

55

Recruited

3,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5267302/

Incorporating freeze-dried strawberry powder into a high-fat ... In a subsequent study, incorporating 40 g freeze-dried strawberry powder into a high-carbohydrate meal with 25 g total fat significantly reduced the 6-h insulin ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002231662500224X

Strawberries Improve Insulin Resistance and Related ... These findings show that a 2.5-serving dose of strawberries consumed daily for 12 wk can improve prediabetes status and overall cardiometabolic profile in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03522974

NCT03522974 | Effects of Freeze Dried Strawberry Powder ... This study aims to examine the effects of 4 weeks of supplementation with two doses of freeze dried strawberry powder (low dose: 13 g/d and high dose: 40 g/d) ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26842771/

A dose-response evaluation of freeze-dried strawberries ... Conclusion: The data support a role of strawberries in improving insulin sensitivity in people with IR.

5. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991(25)01891-8/pdf

Freeze-Dried Strawberries Improve Insulin Resistance and ... Conclusions: Freeze-dried strawberry supplementation showed significant improvements in insulin resistance, CVD biomarkers, and inflammation in adults with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622009026

Freeze-Dried Strawberries Lower Serum Cholesterol and ... Freeze-dried strawberry powder improves lipid profile ... Bioactives in blueberries improve insulin sensitivity in obese, insulin-resistant men and women.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/mnfr.201500845

A dose–response evaluation of freeze‐dried strawberries ... Conclusion: The data support a role of strawberries in improving insulin sensitivity in people with IR.