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RecruitingNCT06528977WDUpdated Jul 30, 2024

Western Diet on Cardiometabolic and Immune Function

An interventional study of Western Diet in Aging and Diet, Healthy, sponsored by University of Delaware. Recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by University of Delaware · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
50 Years to 64 Years
Sex
All
01

Study summary

This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.

Read the detailed description

Aging is the primary risk factor for Alzheimer's disease (AD) which is the most common form of dementia and among the fastest-growing causes of morbidity and mortality in the United States. The risk factors for AD emerge during midlife and are similar to cardiovascular diseases, one of which has particular interest is high blood pressure. The impact of blood vessels and high blood pressure are made worse by poor lifestyle habits, including eating a Western Diet (WD) that contains processed food and high amounts of added sugars (e.g., foods containing high amounts of fructose), with little to no fiber intake from fruits and vegetables. Previous data indicates a 10-day WD can acutely increase triglycerides and blood pressure. These cardiometabolic changes are thought to involve the immune system, however, it is not exactly known how a WD triggers an inflammatory response. This project aims to determine the role of diet-induced changes in gut health and the function of the immune system (T-cells) in midlife adults. It is hypothesized that eating a WD will acutely make the small intestine more permeable, concurrent with activation of the immune system measured via T-cell function. To test this hypothesis, gut health, T-cell function, and blood vessel function will be measured before, during, and after a 10-day WD. The data generated from this project will help bridge the gap in understanding the relation between diet and the immune system. The results will support future grant proposals to the National Institutes of Health aimed at using dietary interventions to protect against high blood pressure and cognitive impairment in mid-life adults.

02

Conditions studied

  • Aging
  • Diet, Healthy

Keywords

  • added sugars
  • western diet
  • cardiometabolic health
  • T-cell function
  • intestinal permeability
03

In context

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ability to provide informed consent
  • men and postmenopausal women aged 50-64 years
  • systolic blood pressure \< 130 mmHg; diastolic blood pressure \< 90 mmHg
  • body mass index (BMI) \<30 kg/m2 and % body fat \< 25% for men and \< 33% for women
  • fasting triglycerides \< 200 mg/dl (\< 2.3 mmol/L)
  • low density lipoprotein (LDL) cholesterol \<160 mg/dl (4.14 mmol/L)
  • fasting plasma glucose \<126 mg/dl (\<7.0 mmol/L)
  • weight stable in the prior 6 months (≤ 2 kg weight change)
  • blood chemistries indicative of normal liver enzymes and renal function (estimated glomerular filtration rate using the Modification of Diet in Renal Disease (MDRD) prediction equation must be >60 ml/min/1.73 m\^2)

Exclusion criteria

Exclusion Criteria:

  • current use of medications or supplements known to lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3 supplement)
  • chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, heart failure, diabetes, chronic kidney disease requiring dialysis, neurological or autoimmune conditions affecting cognition (e.g. Alzheimer's disease or other forms of dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct)
  • major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
  • current or past (i.e., last 3 months) use of anti-hypertensive or other cardiovascular-acting medications known to influence vascular function and/or arterial stiffness
  • current medication use likely to affect central nervous system (CNS) functions (e.g. long active benzodiazepines)
  • concussion within last 2 years and ≥ 3 lifetime concussions
  • heavy alcohol consumption (≥8 drinks/week for women and ≥15 drinks/week for men)
  • recent major change in health status within the previous 6 months (i.e., surgery, significant infection, or illness)
  • current smoking within the past 3 months.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Western Diet

    Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)

    Other: Western Diet

Interventions

  • OtherWestern Diet

    Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)

06

What researchers measure

Primary outcomes

  1. Change in Mean Arterial Blood Pressure (mmHg)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  2. Change in relative brachial artery flow-mediated dilation (%)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  3. Change in absolute brachial artery flow-mediated dilation (mm)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  4. Change in T-cell mitochondria respiration (oxygen consumption rate)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  5. Change in T-cell flow cytometry (%)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  6. Change in intestinal permeability (lactulose : mannitol test)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  7. Change in triglycerides (mg/dL)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

  8. Change in cholesterol (mg/dL)

    Comparison between before, during and after western diet

    Time frame: Over the course of 1-2 months

07

Study locations

1 of 1 sites recruiting
  • University of Delaware
    Newark, Delaware 19713, United States
    • Christopher Martens, Ph.D. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06528977
Lead sponsor
University of Delaware
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Jul 17, 2024
Primary completion
Jul 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 30, 2024

Study contacts

Kevin Decker, Ph.D.
Contact
Deckerkp@udel.edu
(302) 831-8137
Christopher Martens, Ph.D.
principal investigator · University of Delaware

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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