- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628350
Highly Processed Foods and Vascular Health
Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elaina Marinik, PhD
- Phone Number: 540-231-0923
- Email: emarinik@vt.edu
Study Contact Backup
- Name: Kevin Davy, PhD
- Phone Number: 540-231-3487
- Email: kdavy@vt.edu
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Recruiting
- Virginia Polytechnic and State University
-
Contact:
- Kevin P Davy, PhD
- Phone Number: 540-231-3487
- Email: Kdavy@vt.edu
-
Contact:
- Elaina L Marinik, PhD
- Phone Number: 540-231-0923
- Email: emarinik@vt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: No UPF (Ultra-processed foods)
Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% energy) for 6 weeks. The controlled diet is eucaloric (50% carbohydrate, 35% fat,15% protein) 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. Participants will consume a diet containing 0% total energy from UPF for 6 weeks |
Following a two-week eucaloric lead-in diet, participants will be provided and consume a diet without UPF (0% energy).
Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein), 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, for 6 weeks.
|
Experimental: High UPF
Following a 2-week eucaloric lead-in diet, participants will be provided and consume a diet composed of 59% UPF for 6 weeks.
The controlled diet is eucaloric (50% carbohydrate, 35% fat,15% protein) 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.
|
Following a two-week eucaloric lead-in diet, participants will be provided and consume a diet maintaining usual UPF intake (59% energy).
Diets will be eucaloric (50% carbohydrate, 35% fat, 15% protein), 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, for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in brachial artery function from baseline to 6-weeks post no or standard UPF diet
Time Frame: 30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard 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.
|
30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard 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.
|
45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in arterial stiffness (Beta-stiffness index) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Beta-stiffness index will be measured using high resolution ultrasonography and tonometry of the carotid artery.
|
45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in gut microbial composition from baseline to post 6-weeks no or standard UPF diet
Time Frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard 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.
|
3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in gut microbial function from baseline to post 6-weeks no or standard UPF diet
Time Frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard 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.
|
3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in intestinal inflammation from baseline to post 6-weeks no or standard UPF diet
Time Frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Intestinal inflammation will be assessed using fecal calprotectin, lactoferrin, and lipocalin-2, measured using ELISA.
|
3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in intestinal permeability from baseline to post 6-weeks no or standard UPF diet
Time Frame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Intestinal permeability will be assessed using serum zonulin (Immunodiagnostik AG, Bensheim, Germany) concentrations, measured using ELISA.
|
3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in inflammatory cytokines from baseline to post 6-weeks no or standard UPF diet
Time Frame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Inflammatory cytokines, including Tumor Necrosis Factor alpha, Interleukin 6, and Monocyte Chemoattractant Protein-1, will be measured using ELISA (American Diagnostica Inc).
|
5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in endotoxin from baseline to post 6-weeks no or standard UPF diet
Time Frame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Serum endotoxin will be assessed using the PyroGene Recombinant Factor C endotoxin assay (Lonza, Basel, Switzerland).
|
5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin sensitivity from baseline to 6-weeks post no or standard UPF diet
Time Frame: 2-hour test in laboratory, 2 timepoints (baseline, 6-weeks post no or standard UPF diet)
|
Insulin sensitivity assessed using a 2-hour oral glucose tolerance test (75g glucose load).
Blood will be collected at baseline (fasting), and thereafter, at 30-minute intervals (5 total measurements in 2 hours).
|
2-hour test in laboratory, 2 timepoints (baseline, 6-weeks post no or standard UPF diet)
|
Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
24-hour glucose control (24-hour mean glucose concentration) will be assessed using continuous glucose monitoring for a 6-day period.
|
6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in 24-hour glucose control (AUC) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
24-hour glucose control (24-hour AUC) will be assessed using continuous glucose monitoring for a 6-day period.
|
6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in 24-hour glucose control (time in range) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
24-hour glucose control (time in range) will be assessed using continuous glucose monitoring for a 6-day period.
|
6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
24-hour glucose control (GV) will be assessed using continuous glucose monitoring for a 6-day period.
|
6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post no or standard UPF diet
Time Frame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Free-living postprandial glucose concentration will be assessed using continuous glucose monitoring for a 6-day period.
|
6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kevin Davy, PhD, Virginia Polytechnic Institute and State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinActive, not recruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
Clinical Trials on No UPF controlled diet
-
Virginia Polytechnic Institute and State UniversityDuke UniversityRecruitingInsulin Sensitivity | 24-hour Glucose ControlUnited States
-
Purdue UniversityCompletedDiet ModificationUnited States
-
Purdue UniversityCompletedDiet ModificationUnited States
-
University of SurreyBritish Broadcasting CorporationCompleted
-
Penn State UniversityMcCormick Science InstituteCompletedInflammation | Cardiovascular DiseaseUnited States
-
National Institute of Diabetes and Digestive and...CompletedAnorexia Nervosa | Metabolic SyndromeUnited States
-
Université de SherbrookeFonds de la Recherche en Santé du QuébecCompleted
-
Nutrisystem, Inc.University of PennsylvaniaUnknown
-
University of California, San FranciscoCompleted
-
University of Medicine and Dentistry of New JerseyAlmond Board of CaliforniaCompletedMetabolic Syndrome | Insulin Resistance | PrediabetesUnited States