Cardiovascular DiseasesNCT05628350
Highly Processed Foods and Vascular Health
A study of Cardiovascular Diseases, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic and State University
Blacksburg, Virginia, 24061
About this study
Official title: Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults
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
- Being tested
- No UPF controlled diet, High UPF controlled diet
- Keywords
- Middle age, Diet composition, Vascular function
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No UPF controlled dietOther
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.
High UPF controlled dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No UPF (Ultra-processed foods) | Experimental | Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% total energy) for 6 weeks. Receives: Other: No UPF controlled diet |
| High UPF | Experimental | Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet composed of 81% UPF for 6 weeks. Receives: Other: High UPF controlled diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial artery function from baseline to 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.
Measured: 30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet)
Secondary outcomes (7)
Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or high UPF diet
Carotid femoral (C-F) pulse wave velocity (PWV), the primary measure of arterial stiffness, will be measured. C-F waveforms will be obtained via tonometry (NIHem, Cardiovascular Engineering, Inc). Aortic PWV will be calculated from signal averaged waveforms using the ECG as the fiducial point, and body surface measurements.
Measured: 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
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport. Upon return to the lab, they will be immediately frozen at -80°C until final processing and analysis.
Measured: 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
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport. Upon return to the lab, they will be immediately frozen at -80°C until final processing and analysis.
Measured: 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
Intestinal inflammation will be assessed using fecal calprotectin, lactoferrin, and lipocalin-2, measured using ELISA.
Measured: 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
Intestinal permeability will be assessed using serum zonulin (Immunodiagnostik AG, Bensheim, Germany) concentrations, measured using ELISA.
Measured: 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
Inflammatory cytokines, including Tumor Necrosis Factor alpha, Interleukin 6, and Monocyte Chemoattractant Protein-1, will be measured using ELISA (American Diagnostica Inc).
Measured: 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
Serum endotoxin will be assessed using the PyroGene Recombinant Factor C endotoxin assay (Lonza, Basel, Switzerland).
Measured: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start19 Jul 2023
- Primary completion18 Dec 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Kevin Davy, Virginia Polytechnic Institute and State University
- Investigators
- Kevin Davy, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628350
- Sponsor's protocol ID
- 22-819
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT05628350
- Acronym / sponsor ID
- 22-819
- Conditions
- Cardiovascular Diseases
- Keywords
- Middle age, Diet composition, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No UPF (Ultra-processed foods) | Experimental | Other: No UPF controlled dietFollowing a 2-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% total energy) for 6 weeks. |
| High UPF | Experimental | Other: High UPF controlled dietFollowing a 2-week eucaloric lead-in diet, participants will be provided and consume a diet composed of 81% UPF for 6 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No UPF controlled dietFollowing 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 | No UPF (Ultra-processed foods) |
| High UPF controlled dietFollowing 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. | Other | High UPF |
Primary outcome
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.
7 secondary outcomes
Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or high UPF diet
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or high UPF diet)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Davy, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Diseases, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.