Western Diet on Cardiometabolic and Immune Function
University of Delaware · with National Institute of General Medical Sciences (NIGMS) · NCT06528977
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50–64 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- July 17, 2024
- Record last updated
- July 30, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Western Diet
Conditions: Aging; Diet, Healthy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
University of Delaware
Newark, DE 19713
Site contact: Christopher Martens, Ph.D.
Study contacts (from the official record)
- Kevin Decker, Ph.D. · (302) 831-8137 · Deckerkp@udel.edu
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