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Leucine, mTOR and Athero (HPL)

Primary Purpose

Atherosclerosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard protein meal

High protein meal

Low protein meal + leucine

Arm Description

Participants will receive a standard protein meal, containing about 10% of energy as protein

Participants will receive a high protein meal, containing about 50% of energy as protein

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

Outcomes

Primary Outcome Measures

p-mTOR in monocytes

Secondary Outcome Measures

Full Information

First Posted
July 13, 2022
Last Updated
June 16, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05470218
Brief Title
Leucine, mTOR and Athero
Acronym
HPL
Official Title
Protein, Platelet, and Monocyte
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
August 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-group crossover
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard protein meal
Arm Type
Active Comparator
Arm Description
Participants will receive a standard protein meal, containing about 10% of energy as protein
Arm Title
High protein meal
Arm Type
Active Comparator
Arm Description
Participants will receive a high protein meal, containing about 50% of energy as protein
Arm Title
Low protein meal + leucine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Meal
Intervention Description
Liquid mixed meal with different amounts of protein and leucine
Primary Outcome Measure Information:
Title
p-mTOR in monocytes
Time Frame
change from before meal at 1 hour and 3 hours, compared to before

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared upon reasonable request beginning 12 months and ending 36 months following article publication
IPD Sharing Time Frame
beginning 12 months and ending 36 months following article publication

Learn more about this trial

Leucine, mTOR and Athero

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