NCT06768775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2025

Completed
Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

7 months

First QC Date

January 6, 2025

Last Update Submit

October 26, 2025

Conditions

Keywords

Regenerative agricultureConventional farmingFatty acid profilesOmega-3Inflammatory markersMetabolomicsPastured meatNutritional biomarkersDiet interventionHuman health

Outcome Measures

Primary Outcomes (1)

  • Red Blood Cell (RBC) Omega-3 Fatty Acid Levels

    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 Outcomes (1)

  • Metabolomics Profile Analysis

    Baseline to Week 16 (End of Study)

Study Arms (2)

Pastured Livestock Products Group

EXPERIMENTAL

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.

Dietary Supplement: Pastured Livestock Diet

Conventional Livestock Products Group

EXPERIMENTAL

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.

Dietary Supplement: Conventional Livestock Diet

Interventions

Pastured Livestock DietDIETARY_SUPPLEMENT

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.

Pastured Livestock Products Group
Conventional Livestock DietDIETARY_SUPPLEMENT

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.

Conventional Livestock Products Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsOnly participants who self-identify as male or female are eligible for this study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Nutrition Studies

Logan, Utah, 84341, United States

Location

Related Publications (1)

  • 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.

    PMID: 20807460BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 10, 2025

Study Start

March 1, 2025

Primary Completion

September 21, 2025

Study Completion

September 21, 2025

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Decoded metabolomics data will be shared through public repositories such as Metabolomics Workbench to ensure accessibility. Decoded data on inflammatory biomarkers, gut microbiome profiles, and bloodwork results will be included as supplemental information in peer-reviewed publications resulting from this study.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations