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NCT06173765 · ClinicalTrials.gov registry record · NA
Understanding Dose Related Effects of Strawberry
A NA study of PreDiabetes and Inflammation, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology.
- Active
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT06173765: Active NA study of PreDiabetes and Inflammation, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology.
NCT06173765 is a NA study of PreDiabetes and Inflammation that is active but no longer recruiting, run by Clinical Nutrition Research Center, Illinois Institute of Technology. The registered enrollment target is 66 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06173765, a NA study of PreDiabetes and Inflammation, is active but no longer recruiting, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The dose related change in measures of inflammation by analyzing NF-κB activation/suppression in monocytes among participants after 4 weeks of strawberry intake (1 cup or 3 cup FWeq) vs control (0 cup strawberry).
Conditions Studied
Interventions
- OTHER freeze-dried whole strawberry powder 36 g powder
- OTHER freeze-dried whole strawberry powder 12 g
- OTHER freeze-dried control powder 0 g strawberry
Study Locations (1)
Illinois
- Clinical Nutrition Research Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2026-01-28 |
| Phase | NA |
What the registry record for NCT06173765 still lists
NCT06173765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with PreDiabetes appearing as the primary indexed condition, and to 3 interventions - of which freeze-dried whole strawberry powder 36 g powder is the first listed.
NCT06173765 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06173765 about?
NCT06173765 is a clinical study titled "Understanding Dose Related Effects of Strawberry". 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...
What is the current status of trial NCT06173765?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 66 participants. The study started on 2022-08-31. Estimated completion is 2026-01-28.
What conditions does trial NCT06173765 study?
This clinical trial studies the following conditions: PreDiabetes, Inflammation, Insulin Resistance, Insulin Sensitivity.
What interventions are being tested in trial NCT06173765?
The interventions under investigation include: freeze-dried whole strawberry powder 36 g powder (OTHER), freeze-dried whole strawberry powder 12 g (OTHER), freeze-dried control powder 0 g strawberry (OTHER).
Who is sponsoring clinical trial NCT06173765?
This trial is sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology, which has 59 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06173765 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06173765's enrollment target sits among peer trials
66 84th of 149 higher than 65 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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