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ACTIVE NOT RECRUITING
NCT06173765
NA

Understanding Dose Related Effects of Strawberry

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

View on ClinicalTrials.gov

Summary

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.

Official title: Understanding Dose Related Effects of Strawberry Intake on Chronic Inflammation, Oxidative Stress, and Their Relationship With Endothelial Function and Insulin Sensitivity

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-08-31

Completion Date

2026-01-28

Last Updated

2025-07-11

Healthy Volunteers

Yes

Interventions

OTHER

freeze-dried whole strawberry powder 36 g powder

After day 1 measurements, subjects will be given their first intervention drink (powder plus water) according to their randomization to 3 cup FW equivalent of strawberries. The freeze-dried whole strawberry powder (36 g powder) requested from the California Strawberry Commission. All drinks will be standardized to 41 g powder to match USDA Control arm.

OTHER

freeze-dried whole strawberry powder 12 g

After day 1 measurements, subjects will be given their first intervention drink (powder plus water) according to their randomization to 1 cup FW equivalent of strawberries. The freeze-dried whole strawberry powder (12 g powder) requested from the California Strawberry Commission. All drinks will be standardized to 41 g powder to match USDA Control arm.

OTHER

freeze-dried control powder 0 g strawberry

After day 1 measurements, subjects will be given their first intervention drink (powder plus water) according to their randomization to 0 cup FW equivalent of strawberries. The freeze-dried powder is used as a control. All drinks will be standardized to 41 g powder to match USDA Control arm.

Locations (1)

Clinical Nutrition Research Center

Chicago, Illinois, United States