Effects of a Western Diet on Heart and Immune Health
Effects of a 10-day Western Diet on Cardiometabolic and Immune Function in Midlife Adults
This study is testing how a Western diet high in added sugars affects heart health and immune function in middle-aged adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 64 Years |
| Sex | All |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT06528977 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a Western Diet on cardiometabolic and immune function in middle-aged adults aged 50 to 64 years. Participants will follow a 10-day diet consisting of 25% of total energy from added sugars, while researchers will assess vascular health, intestinal permeability, and T-cell function before, during, and after the diet. The goal is to understand how dietary changes influence gut health and immune responses, particularly in relation to aging and cardiovascular health. The findings could provide insights into the relationship between diet and immune system activation.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 50-64 with specific health metrics indicating stable cardiovascular health.
Not a fit: Patients with chronic diseases or those currently taking medications that affect triglycerides or cholesterol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better dietary recommendations that improve cardiometabolic health and immune function in aging populations.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that dietary interventions can significantly impact cardiometabolic health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newark, Delaware
- University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Martens, Ph.D. — University of Delaware
- Study coordinator: Kevin Decker, Ph.D.
- Email: Deckerkp@udel.edu
- Phone: (302) 831-8137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.