Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Virginia Polytechnic Institute and State University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change in brachial artery function from baseline to 6-weeks post no or high UPF diet
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief 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.
Investigators
Kevin Davy
Professor
Virginia Polytechnic Institute and State University
Eligibility Criteria
Inclusion Criteria
- •Weight stable for previous 6 months (\<2 kg change)
- •Sedentary to recreationally active
- •No plans to gain/lose weight or change physical activity level
- •Willing to pick up food daily and consume foods provided for an 8-week period
- •Verbal and written informed consent
- •Approval by Medical Director
- •Usual UPF intake +/-15% of US average of 60% total energy
- •Estrogen or testosterone usage is acceptable, if on stable dose for \>6 months
- •Lipid-lowering medication usage is acceptable, if on a stable dose for \>6 months
Exclusion Criteria
- •BMI \>35 kg/m2
- •Diabetes or diabetes medication
- •Antibiotic, prebiotic or prebiotic use in prior 3 months
- •Total Cholesterol \>6.2 mmol/L; Triglycerides \>4.5 mmol/L
- •Blood pressure (BP) \> 159/99 mmHg (Stable BP on antihypertensive medications is acceptable)
- •Diagnosed inflammatory bowel disease
- •Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
- •Vegetarian or vegan
- •Pregnant or plans to become pregnant
- •Food allergies or aversions
Outcomes
Primary Outcomes
Change in brachial artery function from baseline to 6-weeks post no or high UPF diet
Time Frame: 30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet)
Flow Mediated Dilation (FMD) of the brachial artery will be assessed using duplex ultrasonography (GE Logiq e) with a high-resolution linear array transducer. Reactive hyperemia will be produced by inflation of a pediatric BP cuff around the forearm for 5 minutes. Offline analysis of baseline and post-reactive hyperemic diameters and velocities will be performed using edge detection software (Vascular Analysis Tools, Medical Imaging Applications, Inc). Endothelium independent vasodilation (EID) will be assessed by measuring brachial arterial dilation for 10 minutes following administration of 0.4 mg of sublingual nitroglycerine. Both FMD and EID will be expressed as mm and % change from baseline diameter.
Secondary Outcomes
- Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or high UPF diet(45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in gut microbial composition from baseline to post 6-weeks no or high UPF diet(3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in gut microbial function from baseline to post 6-weeks no or high UPF diet(3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in intestinal inflammation from baseline to post 6-weeks no or high UPF diet(3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in intestinal permeability from baseline to post 6-weeks no or high UPF diet(3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in inflammatory cytokines from baseline to post 6-weeks no or high UPF diet(5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet))
- Change in endotoxin from baseline to post 6-weeks no or high UPF diet(5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet))