Understanding Dose Related Effects of Strawberry

Running, not enrolling · Not applicable

Conditions studied: Pre-diabetes, Insulin Sensitivity, Insulin Resistance, Inflammation

In brief

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.

Key facts

Study ID: NCT06173765
Run by: Clinical Nutrition Research Center, Illinois Institute of Technology
People needed: 66
Starts: 2022-08-31
Expected to finish: 2026-01-28
Last updated by the study team: 2025-07-11

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men or women 20-60 years of age
High sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, >1.0 and ≤10 ng/L
BMI ≥ 25 kg/m2
Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 1 years). Occasional smoker may be allowed at investigator discretion
Judged to be in good health on the basis of the medical history ie., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc.
Able to provide informed consent
Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and study visit schedule)
Able to maintain usual physical activity pattern
Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit

You may not qualify if…

Men and women who smoke regularly
Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
Men and women who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
Men and women who have fasting blood glucose concentration >125 mg/dL at screening visit
Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
Men and women with cancer other than non-melanoma skin cancer in previous 5 years
Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
Women who are known to be pregnant or who are intending to become pregnant over the course of the study
Women who are lactating
Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30-day washout); e.g., fish oil, probiotics, etc...
Men and women who has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
Has a known intolerance or sensitivity to any ingredients in the study products
Has used antibiotics within the previous 2 months
History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
Substance (alcohol or drug) abuse within the last 2 years
Excessive coffee and tea consumers (> 4 cups/d)
Donated blood within last 3 months
Men and women who do excessive exercise regularly or are an athlete
Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
Unusual working hours i.e., working overnight (e.g. 3rd shift)

Where it is running

Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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