Actively Recruiting

Phase Not Applicable
Age: 50Years - 64Years
All Genders
Healthy Volunteers
NCT06528977

Western Diet on Cardiometabolic and Immune Function

Led by University of Delaware · Updated on 2024-07-30

20

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

U

University of Delaware

Lead Sponsor

N

National Institute of General Medical Sciences (NIGMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Western Diet on Cardiometabolic and Immune Function

Who Can Participate

Age: 50Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Men and postmenopausal women aged 50 to 64 years
  • Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 90 mmHg
  • Body mass index (BMI) less than 30 kg/m2 and body fat percentage less than 25% for men and less than 33% for women
  • Fasting triglycerides less than 200 mg/dl
  • Low density lipoprotein (LDL) cholesterol less than 160 mg/dl
  • Fasting plasma glucose less than 126 mg/dl
  • Weight stable for the prior 6 months with 2 kg or less weight change
  • Blood tests showing normal liver enzymes and kidney function with estimated glomerular filtration rate over 60 ml/min/1.73 m2
Not Eligible

You will not qualify if you...

  • Use of medications or supplements that lower blood triglycerides or cholesterol (e.g., fibrates, statins, high dose niacin, high dose omega-3)
  • Chronic clinical diseases such as 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, dementia, Parkinson's disease, epilepsy, multiple sclerosis, large vessel infarct)
  • Major psychiatric disorders like schizophrenia or bipolar disorder
  • Current or past use within 3 months of anti-hypertensive or cardiovascular medications affecting vascular function or arterial stiffness
  • Current use of medications affecting central nervous system function (e.g., long active benzodiazepines)
  • Concussion within the last 2 years or 3 or more lifetime concussions
  • Heavy alcohol consumption (8 or more drinks per week for women, 15 or more drinks per week for men)
  • Major change in health status in the past 6 months such as surgery, significant infection, or illness
  • Smoking within the past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Delaware

Newark, Delaware, United States, 19713

Actively Recruiting

Loading map...

Research Team

K

Kevin Decker, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here