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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 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05628350
The ClinicalTrials.gov registry entry for NCT05628350 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which No UPF controlled diet is the first listed.
NCT05628350 reports 0 study locations.
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.
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