Strawberry Powder for Insulin Sensitivity
(STRW Trial)
Trial Summary
What is the purpose of this trial?
The proposed research is designed to extend previous research findings building on the knowledge of strawberries as fruits that support a healthy immune and vascular system. The proposed research leverages a recently funded proposal by the USDA to study in greater depth inflammation, glucoregulation and oxidative stress defense and their relation to improving endothelial function and insulin sensitivity. Before and after strawberry intake, blood samples will be collected for monocyte (immune cells and source of inflammatory cytokines) isolation and activation via changes in cellular NF-κB and Nrf-2 (key transcription factors of inflammation/oxidative stress defense) status along with products of their activation (ie., plasma cytokines). Because inflammation and oxidative stress impairs endothelial function and insulin sensitivity, acutely and chronically, investigators will also study changes in vascular and insulin sensitivity status, assessing changes in vascular adhesion molecules, endothelial responsiveness through flow mediated vasodilation (ie., FMD) and insulin sensitivity using the Liquid Meal Tolerance (LMTT) if intravenous glucose tolerance test (IVGTT) method cannot be used due to supply chain issues of sterile Dextrose. Glucoregulation will be assessed by placing a Continuous Glucose monitoring (CGM) machine (Dexcom-6) to participants for 10 days at the beginning and at the end of the study period of intervention. The study will be a randomized, double-blinded, 3-arm parallel, 4-week, dose-response study. Individuals with chronic low grade inflammation will be sought to test the anti-inflammation - vaso-relaxing - insulin sensitivity effects of strawberry.
Research Team
Britt Burton-Freeman, Ph.D
Principal Investigator
Illinois Institute of Technology
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in inflammation and insulin sensitivity
Treatment Details
Interventions
- Freeze-dried whole strawberry powder
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Who Is Running the Clinical Trial?
Clinical Nutrition Research Center, Illinois Institute of Technology
Lead Sponsor