NCT06528977 Western Diet on Cardiometabolic and Immune Function
| NCT ID | NCT06528977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Delaware |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-07-17 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) 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.
Contact & Investigator
Christopher Martens, Ph.D.
PRINCIPAL INVESTIGATOR
University of Delaware
Frequently Asked Questions
Who can join the NCT06528977 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 64 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06528977 currently recruiting?
Yes, NCT06528977 is actively recruiting participants. Contact the research team at Deckerkp@udel.edu for enrollment information.
Where is the NCT06528977 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT06528977 clinical trial?
NCT06528977 is sponsored by University of Delaware. The principal investigator is Christopher Martens, Ph.D. at University of Delaware. The trial plans to enroll 20 participants.