Leucine, mTOR and Athero

Atherosclerosis Clinical Trial

— HPL  

Official title:

Protein, Platelet, and Monocyte

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05470218
• Other study ID #: HPL
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: August 14, 2025

Study information

• Verified date: March 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 14, 2025
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• Meal
Liquid mixed meal with different amounts of protein and leucine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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