Status:
RECRUITING
Western Diet on Cardiometabolic and Immune Function
Lead Sponsor:
University of Delaware
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Aging
Diet, Healthy
Eligibility:
All Genders
50-64 years
Phase:
NA
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 ...
Detailed Description
Aging is the primary risk factor for Alzheimer's disease (AD) which is the most common form of dementia and among the fastest-growing causes of morbidity and mortality in the United States. The risk f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06528977
Start Date
July 17 2024
End Date
July 1 2027
Last Update
July 30 2024
Active Locations (1)
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1
University of Delaware
Newark, Delaware, United States, 19713