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OpenTrials
Active, Not Recruiting

NCT Number: NCT05470218

Leucine, mTOR and Athero

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal

Other

Liquid mixed meal with different amounts of protein and leucine

Primary outcomes

  1. p-mTOR in monocytes

    Time frame: change from before meal at 1 hour and 3 hours, compared to before

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Washington University School of Medicine

Registry information

Official study title

Protein, Platelet, and Monocyte

Acronym: HPL

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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