Skip to content

Western Diet on Cardiometabolic and Immune Function

Effects of a 10-day Western Diet on Cardiometabolic and Immune Function in Midlife Adults

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06528977
Acronym
WD
Enrollment
20
Registered
2024-07-30
Start date
2024-07-17
Completion date
2027-07-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Diet, Healthy

Keywords

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

Brief 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.

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.

Interventions

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

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Delaware
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A controlled feeding study prepared by registered dieticians. Participants will be pre-tested, provided a 10-day WD to be tested on day 10, then post-tested.

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Mean Arterial Blood Pressure (mmHg)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in relative brachial artery flow-mediated dilation (%)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in absolute brachial artery flow-mediated dilation (mm)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in T-cell mitochondria respiration (oxygen consumption rate)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in T-cell flow cytometry (%)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in intestinal permeability (lactulose : mannitol test)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in triglycerides (mg/dL)Over the course of 1-2 monthsComparison between before, during and after western diet
Change in cholesterol (mg/dL)Over the course of 1-2 monthsComparison between before, during and after western diet

Countries

United States

Contacts

Primary ContactKevin Decker, Ph.D.
Deckerkp@udel.edu(302) 831-8137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026