Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07121010

Randomized Crossover Trial of Protein Source and Leucine Supplementation on Metabolic and Immune Signaling Pathways

Led by University of Pittsburgh · Updated on 2026-03-25

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how different types of protein, specifically animal-based and plant-based proteins, affect metabolism and the immune system in healthy adults. The trial focuses on the role of leucine, an amino acid that influences the mTOR pathway, which regulates cell growth and may be linked to heart-related diseases like atherosclerosis. The study aims to understand whether adding leucine to plant-based protein can mimic the effects of animal protein on the body. Participants will take part in a randomized, controlled, crossover trial where they consume three different smoothies: one with animal-based protein, one with plant-based protein, and one with plant-based protein plus added leucine. Each smoothie provides 50% of calories from protein and is prepared under controlled conditions following Halal and Kosher guidelines. Participants complete three visits, each involving fasting, smoothie consumption, and blood sample collection before and 1 and 3 hours after drinking the smoothie, with at least 3 days between visits. During the study visits, researchers will collect blood samples to measure amino acid levels, especially leucine, and assess the activity of metabolic and immune pathways including mTORC1 signaling and inflammatory markers like IL-6 and TNF-alpha. The study will analyze changes in these markers to understand how protein source and leucine supplementation affect nutrient sensing and immune responses. Participants are healthy adults aged 18 to 65 years, and the total participation includes three clinic visits with fasting and blood draws at each visit.

CONDITIONS

Brief Title

How Animal and Plant Protein Shakes Change the Body's Nutrient and Health Responses

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Body mass index (BMI) between 18.5 and 29.9 kg/m�b2
  • Generally healthy without known chronic illness or ongoing chronic medication use
  • Willingness to follow dietary restrictions and study procedures
  • Not currently on a prescribed or restrictive diet, such as vegan, ketogenic, or high-protein, and not regularly taking high-protein supplements
Not Eligible

You will not qualify if you...

  • History of cardiovascular disease, diabetes, or autoimmune disorders
  • Current use of anti-inflammatory, immunomodulatory, or lipid-lowering medications
  • Kidney or liver dysfunction
  • Pregnancy or breastfeeding
  • Allergies or intolerances to any ingredients in the study smoothies
  • Participation in another interventional study within the last 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 weeks with a minimum 3-day washout period between each of the 3 visits

Participants consume each of the three different protein smoothies in a randomized order, with blood samples collected before and after consumption to assess metabolic and immune responses.

3 visits (in-person), each including fasting blood draw, smoothie consumption, and post-consumption blood draws at 1 and 3 hours

Trial Site Locations

Total: 1 location

1

UPMC Montefiore - Clinical and Translational Research Center (CTRC)

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

A

Ali Ajam, MD

B

Babak Razani, MD-PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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