Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173765
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-05-22
Brief Title:
Understanding Dose Related Effects of Strawberry
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
Understanding Dose Related Effects of Strawberry Intake on Chronic Inflammation Oxidative Stress and Their Relationship With Endothelial Function and Insulin Sensitivity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRW
Brief 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 inflammationoxidative 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
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 inflammationoxidative 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
Detailed Description:
Investigators are proposing to leverage ongoing research funded by USDA to study in greater depth the effect of strawberry intake on chronic low grade inflammation and its relation to endothelial function and insulin sensitivity InsS Investigators rationale is based on facts that inflammation is a key feature in the development of atherosclerotic cardiovascular disease and diabetes and strawberry intake has been shown to modulate biomarkers of inflammation but with inconsistencies deserving follow up and better understanding Of note meal-induced inflammatory responses seem to be counteracted better with lower amounts of strawberry intake 1 cup fresh weight equivalent FWeq vs 3 cups FWeq In contrast markers of inflammation in the fasting state in humans have been relatively unremarkable showing no or limited change with daily strawberry intake However many of these investigations used higher intake levels 2-3 cup FWeq to test hypotheses on alternative endpoints ie lipids and in groups with varied health risks To better understand the effects of strawberry intake on systemic inflammation investigators propose to study mechanisms ie NF-kBNrf-2 mediated signaling within a sub population of immune cells ie monocytes that result in plasma markers of inflammation Investigators propose to do this by harvesting monocytes from subjects and study the activation of these signaling pathways after 4-week strawberry intake compared to a control condition To address dose-response dynamics investigators propose to study two strawberry intake levels 1 cup FWeq and 3 cup FWeq vs Control Investigators are also interested in expanding recently completed vascular work in our lab showing improved vasodilation by flow mediated vasodilation 1 h after strawberry intake and after 4-week strawberry intake 3 cup FWeq daily in individuals with modestly elevated cholesterol levels Because chronic inflammation and oxidative stress impair endothelial function investigators hypothesize that intake levels of strawberry that have the greatest benefit in reducing inflammation and oxidative stress will align with lower markers of endothelial inflammation and enhanced endothelial function ie vasodilation Dietary patterns and components of the diet that preserve or improve endothelial function have an important risk lowering impact on cardiovascular disease development
And finally investigators aim to explore more deeply the relationship of strawberry intake inflammation and InsS using the Liquid Meal Tolerance LMTT if intravenous glucose tolerance test IVGTT method cannot be used due to supply chain issues of sterile Dextrose Investigators previous work with strawberries is suggestive of improved peripheral InsS in a meal-challenge paradigm in overweight individuals with 1 cup FWeq and in abdominally obese individuals and impaired InsS with 3 cup FWeq Changes in fasting insulin concentrations after intake of strawberries with 1-3 cup FWeq have been neutral
However fasting insulin concentrations give insight about liver InsS and less about peripheral InsS which is relevant in post-meal glucose tolerance In normal physiology a major function of insulin in post meal state is to suppress hepatic gluconeogenesis while stimulating glucose uptake into muscle and fat As impaired InsS is a major risk for developing pre-diabetes and type 2 diabetes intervening early and strategically with diet and with specific foods as science supports to restore InsS is prudent The proposed research can help characterize the role of strawberries in improving InsS and its relation to inflammation status
Glucoregulation will be assessed by placing a Continuous Glucose monitoring CGM machine Dexcom-6 which monitors interstitial glucose levels every 5 minutes for 10 days This will be placed to participants at the beginning of the study for 7-10 days and similarly at the end of the study for 7-10 days of period The study is focused on three areas important to public health and consumers inflammation vascular and metabolic health The project will provide new deeper knowledge in these areas elucidating pathways by which strawberries reduce inflammation and risk for atherosclerotic vascular disease and diabetes The data can contribute to health claim petitions The new knowledge can be used to informeducate a number of stakeholders including the strawberry industry consumers health professionals the scientific medical and regulatory communitiesagencies and contribute to the evidence-base for establishing intake recommendations of polyphenolic rich fruits like strawberries in the USA to promote health and reduce chronic disease risk
And finally investigators aim to explore more deeply the relationship of strawberry intake inflammation and InsS using the Liquid Meal Tolerance LMTT if intravenous glucose tolerance test IVGTT method cannot be used due to supply chain issues of sterile Dextrose Investigators previous work with strawberries is suggestive of improved peripheral InsS in a meal-challenge paradigm in overweight individuals with 1 cup FWeq and in abdominally obese individuals and impaired InsS with 3 cup FWeq Changes in fasting insulin concentrations after intake of strawberries with 1-3 cup FWeq have been neutral
However fasting insulin concentrations give insight about liver InsS and less about peripheral InsS which is relevant in post-meal glucose tolerance In normal physiology a major function of insulin in post meal state is to suppress hepatic gluconeogenesis while stimulating glucose uptake into muscle and fat As impaired InsS is a major risk for developing pre-diabetes and type 2 diabetes intervening early and strategically with diet and with specific foods as science supports to restore InsS is prudent The proposed research can help characterize the role of strawberries in improving InsS and its relation to inflammation status
Glucoregulation will be assessed by placing a Continuous Glucose monitoring CGM machine Dexcom-6 which monitors interstitial glucose levels every 5 minutes for 10 days This will be placed to participants at the beginning of the study for 7-10 days and similarly at the end of the study for 7-10 days of period The study is focused on three areas important to public health and consumers inflammation vascular and metabolic health The project will provide new deeper knowledge in these areas elucidating pathways by which strawberries reduce inflammation and risk for atherosclerotic vascular disease and diabetes The data can contribute to health claim petitions The new knowledge can be used to informeducate a number of stakeholders including the strawberry industry consumers health professionals the scientific medical and regulatory communitiesagencies and contribute to the evidence-base for establishing intake recommendations of polyphenolic rich fruits like strawberries in the USA to promote health and reduce chronic disease risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None