Meal Intake for Atherosclerosis
(HPL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBettina Mittendorfer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Missouri-Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults who can consume milk-based liquid meals. It's not suitable for those with a history of organ transplant, diabetes, heart disease, high blood pressure, stroke or cancer. Pregnant individuals and those allergic to meal ingredients or on certain medications like Rapamycin/Sirolimus and statins cannot participate.

Inclusion Criteria

Can drink a meal made with milk.

I am 18 years old or older.

Exclusion Criteria

I have had cancer in the past.

I have had a stroke in the past.

You are allergic to any of the ingredients in the meal.

+9 more

Participant Groups

The study tests the effects of different protein levels in meals on cardiovascular risk factors. Participants will receive one of three types of liquid meals: low protein, high protein, or low protein with added leucine (which activates mTOR signaling). Blood samples will be taken before and after meal consumption to analyze monocyte and platelet activation.

3Treatment groups

Active Control

Group I: Standard protein mealActive Control1 Intervention

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

Group II: High protein mealActive Control1 Intervention

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

Group III: Low protein meal + leucineActive Control1 Intervention

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