Highly Processed Foods and Vascular Health

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Other: High UPF controlled diet; Other: No UPF controlled diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05628350

22-819

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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
• 3 or fewer stools per week or regular laxative use
• Lipid-lowering medication usage <6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

No UPF (Ultra-processed foods)

Experimental group

Description:

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% total energy) for 6 weeks.

Treatment:

Other: No UPF controlled diet

High UPF

Experimental group

Description:

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet composed of 81% UPF for 6 weeks.

Treatment:

Other: High UPF controlled diet