Western Diet on Cardiometabolic and Immune Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-64
SponsorUniversity of Delaware
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Western Diet
Other interventionConsumption of 10 days of a diet high in added sugars (25% of total caloric intake)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Western DietExperimental treatment 1 intervention
Trial outcomes
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 months2
Change in relative brachial artery flow-mediated dilation (%)
Comparison between before, during and after western diet
Time frame
Over the course of 1-2 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Delaware
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov