An interventional study of Western Diet in Aging and Diet, Healthy, sponsored by University of Delaware. Recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University of Delaware · Not applicable, Interventional, and Health services research
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.
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 factors for AD emerge during midlife and are similar to cardiovascular diseases, one of which has particular interest is high blood pressure. The impact of blood vessels and high blood pressure are made worse by poor lifestyle habits, including eating a Western Diet (WD) that contains processed food and high amounts of added sugars (e.g., foods containing high amounts of fructose), with little to no fiber intake from fruits and vegetables. Previous data indicates a 10-day WD can acutely increase triglycerides and blood pressure. These cardiometabolic changes are thought to involve the immune system, however, it is not exactly known how a WD triggers an inflammatory response. This project aims to determine the role of diet-induced changes in gut health and the function of the immune system (T-cells) in midlife adults. It is hypothesized that eating a WD will acutely make the small intestine more permeable, concurrent with activation of the immune system measured via T-cell function. To test this hypothesis, gut health, T-cell function, and blood vessel function will be measured before, during, and after a 10-day WD. The data generated from this project will help bridge the gap in understanding the relation between diet and the immune system. The results will support future grant proposals to the National Institutes of Health aimed at using dietary interventions to protect against high blood pressure and cognitive impairment in mid-life adults.
University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)
Other: Western Diet
Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)
Change in Mean Arterial Blood Pressure (mmHg)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in relative brachial artery flow-mediated dilation (%)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in absolute brachial artery flow-mediated dilation (mm)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in T-cell mitochondria respiration (oxygen consumption rate)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in T-cell flow cytometry (%)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in intestinal permeability (lactulose : mannitol test)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in triglycerides (mg/dL)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Change in cholesterol (mg/dL)
Comparison between before, during and after western diet
Time frame: Over the course of 1-2 months
Plan to share: No
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