Leucine, MTOR and Athero

Protein, Platelet, and Monocyte

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05470218

Acronym

HPL

Enrollment

Registered

2022-07-22

Start date

2022-07-12

Completion date

2026-08-14

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief summary

High protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. It is controversial if these diets are associated with an increased risk of cardiovascular disease. Recent work in mice has implicated monocytes/macrophages and mTOR signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. We aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mTOR activator) contents on circulating human monocytes and platelets. Study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. Blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. Activation of amino acid-dependent signaling pathways (particularly mTOR) and downstream sequelae will be evaluated in the isolated monocytes and platelets.

Interventions

OTHERMeal

Liquid mixed meal with different amounts of protein and leucine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Single-group crossover

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 years or older * able to drink milk-based liquid mixed meal

Exclusion criteria

* Current Pregnancy * Allergies to meal ingredients * History of Diabetes * History of Heart Disease * History of High blood pressure * History of Stroke * History of Cancer * History of Organ transplant * Taking Rapamycin/Sirolimus * Taking Torisel/Temsirolimus * Taking Afinitor/Everolimus * Taking any statin medication

Design outcomes

Primary

Measure	Time frame
p-mTOR in monocytes	change from before meal at 1 hour and 3 hours, compared to before

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026