Randomized Crossover Trial of Protein Source and Leucine Supplementation on Metabolic and Immune Signaling Pathways
University of Pittsburgh
Summary
The goal of this clinical trial is to learn how different protein types affect the body's metabolism and immune system in healthy adults. The main questions it aims to answer are: Does drinking smoothies with animal-based or plant-based protein change the level of amino acids like leucine in the blood? Does adding leucine to a plant-based smoothie make the body respond like it does to an animal-based smoothie? Participants will: Come to the research clinic for 3 study visits Drink a high-protein smoothie at each visit (one with animal protein, one with plant protein, and one with plant protein + leucine) Give blood samples before and 1 and 3 hours after each smoothie Researchers will look at how the body's metabolism and immune system respond. They are especially interested in a pathway called mTOR, which helps control how cells use nutrients and may be involved in heart disease like atherosclerosis. All smoothies are prepared to meet Halal and Kosher dietary guidelines.
Description
This is a randomized, controlled, crossover clinical trial designed to investigate the acute effects of dietary protein source and leucine supplementation on circulating amino acids and downstream metabolic and immune signaling pathways in healthy adults. The study is being conducted by researchers at the University of Pittsburgh and is based on emerging evidence that dietary protein composition-particularly the type and amount of amino acids such as leucine-may influence key biological processes associated with cardiometabolic health. Proteins are an essential part of the human diet, and dif…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 18-65 years 2. BMI 18.5-29.9 kg/m² 3. Generally healthy, without known chronic illness and/or treatment with chronic medications 4. Willing to comply with dietary restrictions and study procedures 5. Not currently following a prescribed or restrictive diet (for example, vegan, ketogenic or high-protein regimen) or regularly taking high-protein supplements Exclusion Criteria: 1. History of cardiovascular disease, diabetes, or autoimmune disorders 2. Active use of anti-inflammatory, immunomodulatory, or lipid-lowering medications 3. Renal or hepatic dysfunction 4. P…
Interventions
- Dietary SupplementAnimal-Based Protein Smoothie
This smoothie is formulated to deliver 50% of its total caloric content from high-quality animal-based protein, such as whey protein isolate or pasteurized egg whites. It is designed to evaluate the postprandial metabolic and immune response to animal-derived protein sources. The smoothie does not contain any added free amino acids and is prepared in a food-safe certified kitchen under standardized conditions. All participants consume the smoothie after an overnight fast to ensure consistency in metabolic assessment.
- Dietary SupplementPlant-Based Protein Smoothie
This smoothie is formulated to deliver 50% of its total caloric content from plant-based protein, such as pea or rice protein isolate. It is designed to evaluate the postprandial metabolic and immune response to plant-derived protein sources. The smoothie does not contain any added free amino acids and is prepared in a food-safe certified kitchen under standardized conditions. All participants consume the smoothie after an overnight fast to ensure consistency in metabolic assessment.
- Dietary SupplementPlant-Based Protein Smoothie with Leucine
This smoothie is formulated to deliver 50% of its total caloric content from plant-based protein, using sources such as pea or rice protein isolate. In addition, it is supplemented with pharmaceutical-grade leucine to match the leucine content typically found in animal-based protein sources. The smoothie is designed to assess whether leucine supplementation can modulate the postprandial metabolic and immune response to plant-derived protein. It is prepared in a food-safe certified kitchen and consumed after an overnight fast to maintain consistency across study conditions.
Location
- UPMC Montefiore - Clinical and Translational Research Center (CTRC)Pittsburgh, Pennsylvania