High Protein Diet and Atherosclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over study

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard meal

Group Type ACTIVE_COMPARATOR

Standard meal

Intervention Type OTHER

Standard meal

High animal protein meal

Group Type EXPERIMENTAL

High animal protein meal

Intervention Type OTHER

Meal with high animal protein content

High plant protein meal

Group Type EXPERIMENTAL

High plant protein meal

Intervention Type OTHER

Meal with high plant protein content

High plant protein meal with additional leucine

Group Type EXPERIMENTAL

High plant protein meal with additional leucine

Intervention Type OTHER

Meal with high plant protein content and additional leucine

Interventions

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Standard meal

Intervention Type OTHER

High animal protein meal

Meal with high animal protein content

Intervention Type OTHER

High plant protein meal

Meal with high plant protein content

Intervention Type OTHER

High plant protein meal with additional leucine

Meal with high plant protein content and additional leucine

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes