Effects of high protein diets on atherosclerosis
Dissecting the Impact of Dietary Protein on Macrophage mTOR Signaling and Atherosclerosis
This study is testing how different high protein diets affect the buildup of plaque in the arteries for people aged 45 to 75 who are overweight or obese.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT05235464 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different types of high protein diets on atherosclerosis, a major contributor to cardiovascular diseases. Participants aged 45 to 75 with a body mass index between 25 and 40 will be assigned to consume standard meals, high animal protein meals, high plant protein meals, or high plant protein meals with added leucine. The research aims to understand how these dietary variations influence atherosclerotic plaque formation and characteristics. The findings could provide valuable insights into dietary recommendations for reducing cardiovascular disease risk.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 75 with a body mass index between 25 and 40.
Not a fit: Patients outside the age range of 45 to 75 or with a body mass index below 25 or above 39.9 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary guidelines that help reduce the risk of cardiovascular diseases associated with atherosclerosis.
How similar studies have performed: While there is preliminary data from animal models suggesting dietary protein may influence atherosclerosis, this specific approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- University of Missouri School of Medicine — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Bettina Mittendorfer — University of Missouri-Columbia
- Study coordinator: Bettina Mittendorfer, PhD
- Email: b.mittendorfer@missouri.edu
- Phone: 6186103465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.