Leucine, MTOR and Athero (HPL)

University of Missouri (MU)

Status: Active, not recruiting

Conditions: Atherosclerosis

Treatments: Other: Meal

Study type: Interventional

Funder types: Other

Identifiers

NCT05470218

HPL

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

10 participants in 3 patient groups

Standard protein meal

Active Comparator group

Description:

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

Treatment:

Other: Meal

High protein meal

Active Comparator group

Description:

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

Treatment:

Other: Meal

Low protein meal + leucine

Active Comparator group

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

Treatment:

Other: Meal