Clinical Trials Logo
  1. Home
  2. Atherosclerosis
  3. NCT05470218
  4. Details
NCT05470218 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Recruiting NCT06230406 - T-Mem GEne in Atherosclerosis
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02894931 - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed NCT03393377 - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination N/A
Completed NCT02224339 - New Technologies to Determine Carotid Plaque Vulnerability
Completed NCT02268513 - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed NCT02377310 - Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography N/A
Not yet recruiting NCT01923012 - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis Phase 2