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Western Diet on Cardiometabolic and Immune Function

This study is looking at how a "Western Diet" affects the heart, blood vessels, and immune system in healthy adults aged 50-64. Researchers want to understand if eating a diet high in added sugars for 10 days changes your blood pressure and how well your blood vessels work. They will also examine your gut health and immune cell function before, during, and after this diet. To join, you need to be between 50 and 64 years old, have normal blood pressure, a healthy body mass index (BMI), and certain cholesterol and triglyceride levels. The study will measure changes in your blood pressure and blood vessel function to see the diet's impact. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It will involve a specific diet intervention.
What's involved
You would consume a Western Diet, which is high in added sugars, for 10 days. Your vascular health, gut health, and immune cell function will be measured before, during, and after this diet.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure and blood vessel function will be measured over the course of 1-2 months.

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NCT06528977

Western Diet on Cardiometabolic and Immune Function

Recruiting
NAAges 50–64InterventionalHealth services
University of Delaware
~20 participants
Updated 2024-07-30 on ClinicalTrials.gov
What's tested:Western Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mean Arterial Blood Pressure (mmHg)
Measured over Over the course of 1-2 months
+7 more outcomes measured

Conditions

Aging
Diet, Healthy

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Delaware1

Study leadership

  • Christopher Martens, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Delaware

Who to contact

Kevin Decker, Ph.D.
[email protected]
(302) 831-8137
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Change in Mean Arterial Blood Pressure (mmHg)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in relative brachial artery flow-mediated dilation (%)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in absolute brachial artery flow-mediated dilation (mm)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in T-cell mitochondria respiration (oxygen consumption rate)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in T-cell flow cytometry (%)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in intestinal permeability (lactulose : mannitol test)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in triglycerides (mg/dL)Over the course of 1-2 months

    Comparison between before, during and after western diet

  • Change in cholesterol (mg/dL)Over the course of 1-2 months

    Comparison between before, during and after western diet