Skip to main content
Clinical Trials/NCT05470218
NCT05470218Active, not recruitingNot Applicable

Protein, Platelet, and Monocyte

University of Missouri-Columbia2 sites in 1 country10 target enrollmentStarted: July 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
10
Locations
2
Primary Endpoint
p-mTOR in monocytes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 95 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Standard protein meal

Active Comparator

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

Intervention: Meal (Other)

High protein meal

Active Comparator

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

Intervention: Meal (Other)

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

Intervention: Meal (Other)

Outcomes

Primary Outcomes

p-mTOR in monocytes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bettina Mittendorfer

Professor of Medicine

University of Missouri-Columbia

Study Sites (2)

Loading locations...

Similar Trials

Leucine, mTOR and Athero | Clinical Trial