The Impact of Pastured Livestock Food Consumption on Fatty Acid and Metabolomic Profiles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Red Blood Cell (RBC) Omega-3 Fatty Acid Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Red Blood Cell (RBC) Omega-3 Fatty Acid Levels
时间窗: 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).
次要结局
- Metabolomics Profile Analysis(Baseline to Week 16 (End of Study))
研究者
Stephanvanvliet
Assistant Professor
Utah State University