Clinical trial NCT06768775: The Impact of Pastured Livestock Food Consumption on Fatty Acid and Metabolomic Profiles
Official title: The Impact of Pastured Livestock Food Consumption on Fatty Acid and Metabolomic Profiles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Omega 3 Fatty Acids
Keywords: Regenerative agriculture
Conventional farming
Fatty acid profiles
Omega-3
Inflammatory markers
Metabolomics
Pastured meat
Nutritional biomarkers
Diet intervention
Human health
Lead sponsor: Utah State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2025-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to evaluate the effects of consuming meat and eggs from regenerative/pastured versus conventional farming practices on health biomarkers in middle-aged adults. The main questions it aims to answer are:

How does consumption of pastured animal products influence red blood cell omega-3 fatty acid levels, inflammatory markers, and metabolomic profiles compared to conventional animal products?

What are the potential metabolic health benefits or risks associated with consuming animal products from regenerative farming practices?

Researchers will compare participants consuming pastured meat and eggs to those consuming conventional meat and eggs to determine differences in health outcomes.

Participants will:

Consume study-provided chicken thighs, ground beef, ground pork, and eggs for 16 weeks.

Attend clinic visits for blood, urine, and stool sample collection before and after the intervention.

Complete dietary assessments to monitor compliance.

Detailed description: This randomized, double-blind, parallel-arm clinical trial investigates the impact of consuming animal products from regenerative/pastured versus conventional farming practices on fatty acid composition, inflammatory markers, and metabolomic profiles in adults aged 30-65 years. The study aims to address gaps in understanding the nutritional and health implications of farming practices by comparing postprandial inflammatory and metabolic responses to these diets.

Participants will be randomly assigned to one of two groups and provided with weekly allocations of animal-source foods. Dietary compliance will be assessed through 24-hour dietary recalls and food logs. Blood, urine, and stool samples will be collected at baseline and end of study to measure the primary and secondary outcomes, including:

Red blood cell omega-3 fatty acid levels as a marker of cardiovascular health. A panel of inflammatory markers, including IL-6, TNF-alpha, CRP.

Plasma metabolites such as amino acids, organic acids, and vitamin derivatives.

Lipid profiles (LDL, HDL, VLDL, cholesterol, and triglycerides). Participants will be instructed to consume only the foods provided by the study to ensure dietary control and reduce confounding factors. Biospecimens will be stored for future analysis to examine broader metabolic impacts.

By addressing how different farming practices influence health markers, this study aims to provide evidence-based insights for public health and inform dietary recommendations for sustainable and health-conscious food systems.

Eligibility criteria: Inclusion Criteria:

* Age between 30 and 65 years. BMI between 25 and 35 kg/m². Weight stability within the last three months (loss or gain \< 4%). Hemoglobin A1C (HbA1C) ≤ 6.4%. Fasting plasma glucose concentration \< 126 mg/dL. Ability to understand and communicate in English or Spanish.

Exclusion Criteria:

* Use of medications known to affect study outcomes (e.g., NSAIDs, corticosteroids, anticoagulants) that cannot be discontinued temporarily.

Blood pressure ≥ 140/90 mmHg without physician clearance. Unwillingness to forgo seafood consumption or omega-3 supplement intake during the study.

Alcohol consumption \> 14 drinks per week. Tobacco product use within the last three months. Receipt of a COVID vaccine within the last two weeks. Engagement in high-level competitive exercise (e.g., triathlon, marathon, powerlifting).

Diagnosed inflammatory diseases (e.g., autoimmune disorders, coeliac disease, arthritis).

Diagnoses of active malignancy, congestive heart failure, diabetes mellitus, or chronic obstructive pulmonary disease.

Use of antibiotics within the last 60 days. Pregnancy or planning pregnancy within the next month. Lactating women. Allergies to meat or eggs. Inability or unwillingness to comply with the study protocol, including adherence to study visits and dietary requirements.

Dietary preferences that exclude meat or eggs (e.g., vegan, vegetarian, halal). Any condition that, in the opinion of the research team, makes the participant unsuitable for the study.

Primary outcomes:
measure: Red Blood Cell (RBC) Omega-3 Fatty Acid Levels
timeFrame: Baseline and 16 weeks (end of intervention).
Secondary outcomes:
measure: Metabolomics Profile Analysis
timeFrame: Baseline to Week 16 (End of Study)
Other outcomes:
Locations:
city: Logan
country: United States
facility: Center for Human Nutrition Studies
state: Utah
Study officials:
References:
citation: McAfee AJ, McSorley EM, Cuskelly GJ, Fearon AM, Moss BW, Beattie JA, Wallace JM, Bonham MP, Strain JJ. Red meat from animals offered a grass diet increases plasma and platelet n-3 PUFA in healthy consumers. Br J Nutr. 2011 Jan;105(1):80-9. doi: 10.1017/S0007114510003090.