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NCT05628350 · ClinicalTrials.gov registry record · NA
Highly Processed Foods and Vascular Health
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT05628350: Completed NA study, sponsored by Virginia Polytechnic Institute and State University.
NCT05628350 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628350, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- OTHER No UPF controlled diet
- OTHER High UPF controlled diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-07-19 |
| Est. Completion | 2025-09-30 |
| Phase | NA |
What the finished NCT05628350 record still lists
NCT05628350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which No UPF controlled diet is the first listed.
NCT05628350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05628350 about?
NCT05628350 is a clinical study titled "Highly Processed Foods and Vascular Health". 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. Ultr...
What is the current status of trial NCT05628350?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2023-07-19. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT05628350?
The interventions under investigation include: No UPF controlled diet (OTHER), High UPF controlled diet (OTHER).
Who is sponsoring clinical trial NCT05628350?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05628350's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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