Clinical trial NCT05628350: Highly Processed Foods and Vascular Health
Official title: Reducing Highly Processed Foods to Improve Vascular Health in Middle-Aged Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2022-11-28
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in brachial artery function from baseline to 6-weeks post no or standard UPF diet
timeFrame: 30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
Secondary outcomes:
measure: Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in arterial stiffness (Beta-stiffness index) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in gut microbial composition from baseline to post 6-weeks no or standard UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in gut microbial function from baseline to post 6-weeks no or standard UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in intestinal inflammation from baseline to post 6-weeks no or standard UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in intestinal permeability from baseline to post 6-weeks no or standard UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in inflammatory cytokines from baseline to post 6-weeks no or standard UPF diet
timeFrame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in endotoxin from baseline to post 6-weeks no or standard UPF diet
timeFrame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
Other outcomes:
measure: Change in insulin sensitivity from baseline to 6-weeks post no or standard UPF diet
timeFrame: 2-hour test in laboratory, 2 timepoints (baseline, 6-weeks post no or standard UPF diet)
measure: Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in 24-hour glucose control (AUC) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in 24-hour glucose control (time in range) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
measure: Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post no or standard UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post no or standard UPF diet)
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic and State University
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Kevin Davy, PhD
role: PRINCIPAL_INVESTIGATOR
References: