- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768775
The Impact of Pastured Livestock Food Consumption on Fatty Acid and Metabolomic Profiles
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
-
Logan, Utah, United States, 84341
- Center for Human Nutrition Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pastured Livestock Products Group
Participants in this group will consume meat and eggs sourced from regenerative/pastured farming practices.
Weekly allocations include chicken (300-500g), beef (500-700g), pork (300-500g), and 8-12 eggs, depending on the habitual caloric intake of participants.
These products are provided for the 16-week intervention, with adherence monitored through dietary logs and 24-hour recalls.
|
Participants will consume a diet consisting of animal-source foods (chicken, beef, pork, and eggs) from regenerative/pastured farming practices.
Foods will be provided weekly in specific quantities for a 16-week intervention.
Adherence will be monitored through dietary logs and ASA24 dietary assessments.
|
|
Experimental: Conventional Livestock Products Group
Participants in this group will consume meat and eggs sourced from conventional farming practices.
Weekly allocations include chicken (300-500g), beef (500-700g), pork (300-500g), and 8-12 eggs, depending on the habitual caloric intake of participants.
These products are provided for the 16-week intervention, with adherence monitored through dietary logs and 24-hour recalls.
|
Participants will consume a diet consisting of animal-source foods (chicken, ground, pork, and eggs) from conventional farming practices.
Foods will be provided weekly in specific quantities for a 16-week intervention.
Adherence will be monitored through dietary logs and ASA24 dietary assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Red Blood Cell (RBC) Omega-3 Fatty Acid Levels
Time Frame: Baseline and 16 weeks (end of intervention).
|
Assessment of changes in red blood cell omega-3 fatty acid composition as a marker of cardiovascular health.
Blood samples will be collected at baseline and after the 16-week intervention to measure levels using gas chromatography-mass spectrometry (GC and LC/MS).
|
Baseline and 16 weeks (end of intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabolomics Profile Analysis
Time Frame: Baseline to Week 16 (End of Study)
|
Changes in plasma metabolomic profiles will be assessed to identify variations in metabolites, such as amino acids, organic acids, and vitamin derivatives, associated with the consumption of pastured versus conventional animal products.
This analysis will provide insights into the biochemical impacts of dietary interventions on metabolic pathways, inflammation, and overall health.
Samples will be analyzed using mass spectrometry for untargeted and/or targeted metabolomics profiling.
|
Baseline to Week 16 (End of Study)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Omega 3 Fatty Acids
-
Universidad de GranadaFundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalRecruiting
-
Fatty Acid Research InstituteOmegaquant Analytics, LLCNot yet recruiting
-
Josip Juraj Strossmayer University of OsijekUnknownOmega-3 Polyunsaturated Fatty AcidsCroatia
-
USDA Grand Forks Human Nutrition Research CenterUnited States Department of Agriculture (USDA); University of North DakotaCompletedOmega-3 Fatty Acids | Lipid PeroxidationUnited States
-
Medical University of South CarolinaAker Biomarine Antarctic ASCompletedFatty Acids, Omega-3 | Cognition | Nutrition | Resilience, Psychological | Psychology, MilitaryUnited States
-
Riga Stradins UniversityCompletedSupplementation | Lipid Metabolism | Omega-3 Polyunsaturated Fatty AcidsLatvia
-
University of HohenheimCompletedMicronutrients | Human Nutrition, Omega-3 Fatty Acids, MicroalgaeGermany
-
University of ArizonaGeorgetown University; National Center for Complementary and Integrative Health...RecruitingCardiovascular Diseases | Omega 3 Fatty Acids | Heart Health MarkersUnited States
-
Wageningen University and ResearchCompletedNutrition | Omega 3 Fatty Acids | Absorption, Metabolism and Excretion in Healthy Volunteers | Fish OilsNetherlands
-
Indiana UniversityNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingOmega-3 Fatty Acids | Subconcussive Head ImpactUnited States
Clinical Trials on Pastured Livestock Diet
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedMental Disorders | Multiple TraumaCongo
-
University of FloridaUnited States Agency for International Development (USAID)CompletedNutritionBurkina Faso
-
Washington State UniversityUNICEF; Food and Agriculture Organization of the United NationsCompleted
-
Hanoi University of Public HealthKarolinska Institutet; University of Copenhagen; Linkoeping University; National... and other collaboratorsRecruitingAntibiotic Resistant Infection | Carbapenem-Resistant Enterobacteriaceae InfectionVietnam
-
Medical University of WarsawCompletedDietary Intervention | Metabolic Cardiovascular Syndrome | Vegetarian Diet | Mediterranean Diet | Vegan Diet | Obesity and OverweightPoland
-
Maastricht University Medical CenterNational Cattlemen's Beef AssociationRecruitingMuscle Protein Synthetic Response to ProteinNetherlands
-
Laval UniversityDairy Farmers of Canada; Agriculture and Agri-Food CanadaCompleted
-
Tufts Medical CenterCompletedObesity | Cardiovascular Disease | Metabolic Syndrome
-
University of PittsburghCompletedCardiovascular Diseases | ObesityUnited States
-
Universidad del Centro Educativo LatinoamericanoUniversidad Nacional de RosarioRecruitingNutrition | Cardiovascular (CV) Risk | Cardiometabolic Health IndicatorsArgentina