| NCT ID | NCT05235464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-03-13 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Atherosclerosis is the underlying cause of the majority of cardiovascular diseases, including myocardial infarction and strokes, and results in tremendous morbidity and mortality. A Western-type diet is a major risk factor for atherosclerosis because of the high saturated fat, cholesterol, and refined carbohydrate contents. Dietary strategies to reduce cardiovascular disease burden therefore focus on restriction of saturated fat, cholesterol, and refined carbohydrates whereas "lean" protein intake is recommended and has become popular. However, results from studies conducted in animal models suggest high dietary protein intake is also atherogenic. The investigators' extensive preliminary data in animal models show that dietary protein increases atherosclerotic plaque formation and size and promotes necrotic core formation, a characteristic of rupture-prone plaques. The goal of the current proposal is to provide deeper insights into the relationship between protein intake and the pathogenesis of atherosclerosis by studying the mechanisms involved in protein-mediated atherogenesis and formation of necrotic plaques. The overarching hypothesis is that high protein intake drives atherosclerosis via leucine-mediated mTORC1 signaling in macrophages, which inhibits macrophage mitophagy and aggrephagy and stimulates macrophage proliferation. Furthermore, the investigators hypothesize that proteins from animal sources are more atherogenic than proteins from plant sources, because animal proteins contain more leucine than plant proteins. The investigators will test these hypotheses by using a sophisticated array of experimental strategies, including assays in primary macrophages and human monocyte-derived macrophages and genetically engineered mouse models. In addition, they will begin to translate the results obtained in vitro and in animals to people, and explore approaches to pharmacologically target the pro-atherogenic pathways as novel cardiovascular therapeutics. This proposal represents a paradigm shift in how a Western-type diet affects vascular health which has important implications since many adults in Western societies consume excess protein and dietary protein is heavily marketed for its presumed beneficial health effects.
Eligibility Criteria
Inclusion Criteria: * \>=45 and \<=75 years of age * body mass index \>=25.0 and \<40.0 kg/m2 Exclusion Criteria: * \<45 and \>75 years of age * body mass index \<25.0 or \>39.9 kg/m2 * plasma triglyceride \<125 mg/dl * history of or current significant organ system dysfunction * allergies or intolerances to meal ingredients * use of medications or dietary supplements that could confound the study outcomes * engaged in regular structured exercise \>150 min per week * alcohol use disorder * premenopausal women * persons who smoke * prisoners * inability to grant voluntary informed consent
Contact & Investigator
Bettina Mittendorfer
PRINCIPAL INVESTIGATOR
University of Missouri-Columbia
Frequently Asked Questions
Who can join the NCT05235464 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05235464 currently recruiting?
Yes, NCT05235464 is actively recruiting participants. Contact the research team at b.mittendorfer@missouri.edu for enrollment information.
Where is the NCT05235464 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT05235464 clinical trial?
NCT05235464 is sponsored by University of Missouri-Columbia. The principal investigator is Bettina Mittendorfer at University of Missouri-Columbia. The trial plans to enroll 24 participants.