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Diet Modification for Cardiovascular Health

N/A

Recruiting

Led By Kevin Davy, PhD

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard upf diet)

Awards & highlights

Study Summary

This trial explores how reducing ultra-processed foods in middle-aged adults may improve their vascular health and reduce risks of CVD.

Who is the study for?

This trial is for middle-aged adults who are sedentary to moderately active, have a stable weight, and consume a diet with ultra-processed foods close to the US average. They must not plan on changing their diet or exercise routine and should be willing to eat provided food for 8 weeks. Exclusions include those with high cholesterol/triglycerides, BMI over 35, vegetarians/vegans, certain diseases, allergies or aversions to food, irregular bowel movements/laxative use, recent antibiotic/prebiotic/probiotic use.Check my eligibility

What is being tested?

The study tests how cutting down on ultra-processed foods affects vascular health in middle-aged adults. Participants will follow either no UPF controlled diet or a standard UPF controlled diet for eight weeks while researchers monitor changes in vascular function and potential mechanisms like gut microbiota composition and inflammation.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication or invasive procedures, side effects may include digestive discomfort as the body adjusts to different levels of processed foods intake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard upf diet)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard upf diet)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard upf diet) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in brachial artery function from baseline to 6-weeks post no or standard UPF diet

Secondary outcome measures

Change in arterial stiffness (Beta-stiffness index) from baseline to 6-weeks post no or standard UPF diet

Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or standard UPF diet

Change in endotoxin from baseline to post 6-weeks no or standard UPF diet

+5 more

Other outcome measures

Change in 24-hour glucose control (24-hour mean) from baseline to 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

Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post no or standard UPF diet

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: No UPF (Ultra-processed foods)Experimental Treatment1 Intervention

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

Group II: High UPFExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor

143 Previous Clinical Trials

27,771 Total Patients Enrolled

Duke UniversityOTHER

2,364 Previous Clinical Trials

3,420,600 Total Patients Enrolled

Kevin Davy, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University

4 Previous Clinical Trials

76 Total Patients Enrolled

Media Library

No UPF controlled diet Clinical Trial Eligibility Overview. Trial Name: NCT05628350 — N/A

Cardiovascular Disease Research Study Groups: High UPF, No UPF (Ultra-processed foods)

Cardiovascular Disease Clinical Trial 2023: No UPF controlled diet Highlights & Side Effects. Trial Name: NCT05628350 — N/A

No UPF controlled diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628350 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is participation in this research endeavor open?

"The current medical trial is enlisting 42 individuals aged between 45 and 65, suffering from a cardiovascular disorder. Further requirements include weight stability over the previous 6 months (<2 kg change), activity levels ranging from sedentary to recreational, signed informed consent forms, dietary adherence within 15% of the US average (60%), stable estrogen or testosterone doses for more than 6 months, no plans to modify physical activity level or bodyweight in either direction. Furthermore, participants should be willing to collect food daily and consume items provided throughout an 8-week period while usage of lipid-lowering medication that has been on steady dose for >6 months will also be"

Answered by AI

Are participants being admitted to this trial at the present time?

"As indicated on clinicaltrials.gov, this particular trial has concluded its participant recruitment process; the study was first posted in January 1st of 2023 and last edited by November 16th 2022. Although there are no longer any openings for this medical research project, 418 other studies need volunteers at present."

Answered by AI

Is admission to the trial contingent upon age, with those over 40 years being excluded?

"This research necessitates that participants are between 45 and 65 years of age. Specifically, 27 clinical trials cater to minors under 18 and 372 medical studies have been designed for senior citizens older than 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Highly Processed Foods and Vascular Health

Kevin Davy 2023. "Highly Processed Foods and Vascular Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05628350.