Status:
COMPLETED
Monocyte Priming When Consuming a Western Diet
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Diseases
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
To determine the mechanism of monocyte priming in humans, the study team will conduct a complete feeding trial in normal weight and metabolically healthy human subjects (20-45 years of age) using a we...
Detailed Description
The goal is to challenge metabolically healthy human subjects with a high-calorie, Western diet for 8 weeks to identify the metabolite(s) responsible for monocyte priming and use redox proteomics, RNA...
Eligibility Criteria
Inclusion
- Age 20-45
- Planning to be available for the entire study period
- Able to speak and read English
- Normal weight (body mass index 18.5-24.9 kg/m2)
- Able to eat the prescribed diet
- Non-smoker
Exclusion
- Excessive alcohol consumption
- History of chronic cardiometabolic disease or major risk factor, including diabetes, hypertension, hyperlipidemia, heart disease
- History of prior surgical procedure for weight control or liposuction
- Use of weight loss medications in previous 6 months
- Recent self-reported weight change
- Severe pulmonary disease requiring supplemental oxygen
- Abnormal renal or liver function
- History of non-skin cancer in the past 5 years
- Regular use of medications (prescribed or over-the-counter) that affect blood pressure, lipids, glucose, inflammation, or body weight
- Works night shifts
- Exercise per week \> 420 minutes total for moderate activity or \> 210 minutes for vigorous activity
- Any medical or behavioral indication that would make participation unsafe based on the judgement of the study physician
- Pregnant or lactating women
- Known or discovered intolerances, allergies or difficulty consuming any of the foods included in the study diets
Key Trial Info
Start Date :
January 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05348395
Start Date
January 6 2023
End Date
October 11 2024
Last Update
March 6 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157