Leucine, MTOR and Athero

Not Applicable

Active, not recruiting

• Conditions: Atherosclerosis
• Interventions: Other: Meal

• Registration Number: NCT05470218
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Primary Completion: 2023-08-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Completion: 2026-08-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard protein meal	Meal	Participants will receive a standard protein meal, containing about 10% of energy as protein
High protein meal	Meal	Participants will receive a high protein meal, containing about 50% of energy as protein
Low protein meal + leucine	Meal	Participants will receive a standard protein meal, containing about 10% of energy as protein to which leucine has been added to match the total leucine content of the high protein meal

Primary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States