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NCT05628350
Highly Processed Foods and Vascular Health
Conditions: Cardiovascular Diseases
Sex: All
Ages: 45 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 42
Sponsor: Virginia Polytechnic Institute and State University
Location: United States
Summary
Age is the primary risk factor for cardiovascular disease (CVD) and age-related vascular dysfunction is considered the key process linking the two.
Middle age is a particularly vulnerable period when risk factors exceed diagnostic thresholds and clinical expression of CVD first becomes evident.
Ultra-processed foods (UPF) comprise almost 60% of total energy in the standard American diet.
The results of observational studies suggest that UPF consumption increases CVD risk, independent of overall diet quality (i.e., saturated fat, sodium, sugar, and dietary fiber intake).
The "industrialized microbiota" may link diet, particularly UPF, to increased inflammation and CVD in middle-aged adults.
High intake of UPF increases the likelihood of an excess heart age >10 years and doubles the risk of subclinical coronary atherosclerosis in middle-aged adults.
However, the impact of reducing UPF consumption on vascular function in middle-aged adults is unknown.
The overall objective of this study is to establish proof-of-concept for an improvement in vascular function following reductions in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future.
In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences vascular function will be investigated.
Eligibility Criteria
Inclusion Criteria:Weight stable for previous 6 months (<2 kg change)Sedentary to recreationally activeNo plans to gain/lose weight or change physical activity levelWilling to pick up food daily and consume foods provided for an 8-week periodVerbal and written informed consentApproval by Medical DirectorUsual UPF intake +/-15% of US average of 60% total energyEstrogen or testosterone usage is acceptable, if on stable dose for >6 monthsLipid-lowering medication usage is acceptable, if on a stable dose for >6 monthsExclusion Criteria:BMI >35 kg/m2Diabetes or diabetes medicationAntibiotic, prebiotic or prebiotic use in prior 3 monthsTotal Cholesterol >6.2 mmol/L; Triglycerides >4.5 mmol/LBlood pressure (BP) > 159/99 mmHg (Stable BP on antihypertensive medications is acceptable)Diagnosed inflammatory bowel diseasePast or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological diseaseVegetarian or veganPregnant or plans to become pregnantFood allergies or aversions3 or fewer stools per week or regular laxative useLipid-lowering medication usage <6 months
Source: ClinicalTrials.gov (NCT05628350). StuddyBuddy aggregates publicly available trial information.