Who is eligible for clinical trial NCT06528977?

Participants must meet protocol criteria for Aging. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06528977 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-07-29

Western Diet on Cardiometabolic and Immune Function (NCT06528977)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Delaware

🩺 Plain-English Summary (8th-Grade Level)

This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).

Location: University of Delaware — Newark, Delaware

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

ability to provide informed consent
men and postmenopausal women aged 50-64 years
systolic blood pressure \< 130 mmHg; diastolic blood pressure \< 90 mmHg
body mass index (BMI) \<30 kg/m2 and % body fat \< 25% for men and \< 33% for women
fasting triglycerides \< 200 mg/dl (\< 2.3 mmol/L)
low density lipoprotein (LDL) cholesterol \<160 mg/dl (4.14 mmol/L)
fasting plasma glucose \<126 mg/dl (\<7.0 mmol/L)
weight stable in the prior 6 months (≤ 2 kg weight change)
blood chemistries indicative of normal liver enzymes and renal function (estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) prediction equation must be \>60 ml/min/1.73 m\^2)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3 supplement)
chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease requiring dialysis, neurological or autoimmune conditions affecting cognition (e.g. Alzheimer's disease or other forms of dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct)
major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
current or past (i.e., last 3 months) use of anti-hypertensive or other cardiovascular-acting medications known to influence vascular function and/or arterial stiffness
current medication use likely to affect central nervous system (CNS) functions (e.g. long active benzodiazepines)
concussion within last 2 years and ≥ 3 lifetime concussions
heavy alcohol consumption (≥8 drinks/week for women and ≥15 drinks/week for men)
recent major change in health status within the previous 6 months (i.e., surgery, significant infection, or illness)
current smoking within the past 3 months.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Delaware — Newark, Delaware

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗