How Animal and Plant Protein Shakes Change the Body's Nutrient and Health Responses
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT07121010
- Status
- Recruiting
Conditions
- Cardiometabolic Health
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Animal-Based Protein Smoothie — DIETARY_SUPPLEMENTThis 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.
- Plant-Based Protein Smoothie — DIETARY_SUPPLEMENTThis 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.
- Plant-Based Protein Smoothie with Leucine — DIETARY_SUPPLEMENTThis 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.
Study Details
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.
Key Dates
- Start date
- Mar 24, 2026
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Animal → Plant → Plant+LeucineParticipants in this arm will receive the animal-based protein smoothie during their first visit, the plant-based protein smoothie during their second visit, and the plant-based protein smoothie with added leucine during their third visit. All study visits follow the same protocol, including fasting, blood draws, and postprandial assessments.
- Experimental: Plant-Based → Plant-Based with Leucine → Animal-BasedParticipants in this arm will receive the plant-based protein smoothie first, the plant-based protein smoothie with leucine second, and the animal-based protein smoothie third. All clinical procedures are the same across visits.
- Experimental: Plant-Based with Leucine → Animal-Based → Plant-BasedParticipants in this arm will receive the plant-based protein smoothie with leucine at their first visit, the animal-based smoothie second, and the plant-based protein smoothie third. The same procedures will be followed at each visit.
Primary Outcome Measure
Change in Circulating Serum Leucine Concentration [ Time Frame: From enrollment to final blood draw at 4 weeks ]
Central Contacts
- Ali Ajam, MD412-512-1044
- Babak Razani, MD-PhD412-648-7496
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Montefiore - Clinical and Translational Research Center (CTRC) | Pittsburgh | Pennsylvania | 15213 | - |
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