NCT05628350

Highly Processed Foods and Vascular Health

Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	No UPF controlled diet	Following a two-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% total energy) for 6 weeks. Diets will be eucaloric (50% carbohydrate, 35% fat, 15% protein) and matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality.
OTHER	High UPF controlled diet	Following a two-week eucaloric lead-in diet, participants will be provided and consume a diet with high UPF intake (81% total energy) for 6 weeks. Diets will be eucaloric (50% carbohydrate, 35% fat, 15% protein) and matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, pre- and probiotics, and overall diet quality.

Timeline

• Start date: 2023-07-19
• Primary completion: 2024-12-18
• Completion: 2025-09-30
• First posted: 2022-11-28
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States