Leucine, mTOR and Athero | NCT05470218

Studies
Leucine, mTOR and Athero

NCT05470218

Sponsor

University of Missouri-Columbia

Status

Active, not recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Atherosclerosis

Interventions

Meal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2022Actual

Primary Completion Date

Aug 14, 2023Actual

Completion Date

Aug 14, 2026Estimated

First Submitted Date

Jul 13, 2022

First Submission Date that Met QC Criteria

Jul 20, 2022

First Posted Date

Jul 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bettina Mittendorfer, Professor of Medicine, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Name	Class
Washington University School of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard protein meal	Active Comparator	Participants will receive a standard protein meal, containing about 10% of energy as protein	Other: Meal
High protein meal	Active Comparator	Participants will receive a high protein meal, containing about 50% of energy as protein	Other: Meal
Low protein meal + leucine	Active Comparator	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	Other: Meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meal	Other	Liquid mixed meal with different amounts of protein and leucine	High protein meal Low protein meal + leucine Standard protein meal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
p-mTOR in monocytes		change from before meal at 1 hour and 3 hours, compared to before

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bettina Mittendorfer	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data will be shared upon reasonable request beginning 12 months and ending 36 months following article publication

Types

Study Protocol

Time Frame

beginning 12 months and ending 36 months following article publication

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062407	Meals

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided