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Official title Western Diet on Cardiometabolic and Immune Function
ClinicalTrials.gov ID: NCT06528977
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose...
- chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease...
- 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...
- 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
See the full eligibility 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)
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.