Western Diet on Cardiometabolic and Immune Function

NCT06528977 | Recruiting

• 2 other identifiers: 2199946P20GM113125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Diet, Healthy

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Change in Mean Arterial Blood Pressure (mmHg)

  Comparison between before, during and after western diet

  Over the course of 1-2 months

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

  Comparison between before, during and after western diet

  Over the course of 1-2 months

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

  Comparison between before, during and after western diet

  Over the course of 1-2 months

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

  Comparison between before, during and after western diet

  Over the course of 1-2 months

• Change in T-cell flow cytometry (%)

  Comparison between before, during and after western diet

  Over the course of 1-2 months

• Change in intestinal permeability (lactulose : mannitol test)

  Comparison between before, during and after western diet

  Over the course of 1-2 months

• Change in triglycerides (mg/dL)

  Comparison between before, during and after western diet

  Over the course of 1-2 months

• Change in cholesterol (mg/dL)

  Comparison between before, during and after western diet

  Over the course of 1-2 months

Study Arms (1)

Western Diet

EXPERIMENTAL

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

Other: Western Diet

Interventions

Western Diet OTHER

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

Western Diet

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Interventions

Diet, Western

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Christopher Martens, Ph.D.

  University of Delaware

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Decker, Ph.D.

CONTACT

(302) 831-8137; Deckerkp@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 30, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)