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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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