Monocyte Priming When Consuming a Western Diet (NCT05348395) | Clinical Trial Compass
CompletedNot Applicable
Monocyte Priming When Consuming a Western Diet
United States8 participantsStarted 2023-01-06
Plain-language 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 western diet (WD), characterized as being high-saturated fat, high-fructose, and high-calorie for 8 weeks.
Who can participate
Age range
20 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity
Timeframe: Baseline (experimental phase)
2
Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity