Dose-dependent Identification of Unique Biomarkers

Study Overview
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Brief Summary
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The purpose of the research is to assess the dose-dependent impacts of the consumption of fresh pork on blood-borne metabolites (markers) following the controlled feeding of pork

Detailed Description
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Eligible participants will follow 3 randomly ordered 4-week feeding periods varying only with the consumption of 0, 3 or 6 oz of pork or a 50:50 blend of chicken and beef (6, 3 and 0 oz for respective trials to ensure similar total poultry/meat intake among trials).

Official Title
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Personalized Pork: Dose-dependent Identification of Unique Biomarkers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Pork Consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally healthy (i.e., an absence of diagnosed chronic illnesses and inborn metabolic disorders) Age 18-65 all races both sexes willingness to comply with the research diet requirements Exclusion Criteria: special dietary needs (e.g., vegetarianism, gluten-free, etc.) use of medication known to influence metabolism smoking substance use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3 conditions, order randomly allocated
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 oz Pork<br>Participants receive 0 oz pork and 6 oz 50:50 blend of chicken and beef per day | Dietary Supplement: Pork Consumption<br>* Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.<br>|
| Experimental: 3 oz Pork<br>Participants receive 3 oz pork and 3 oz 50:50 blend of chicken and beef per day | Dietary Supplement: Pork Consumption<br>* Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.<br>|
| Experimental: 6 oz Pork<br>Participants receive 6 oz pork and 0 oz 50:50 blend of chicken and beef per day | Dietary Supplement: Pork Consumption<br>* Feeding of pork is controlled at 0, 3 or 6 oz per day for 4 weeks each in random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic biomarker discovery | Biomolecules detected through metabolomic profiling that will result in discovery of a metabolic signature for pork intake | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasted Glucose | Fasted Glucose | 4 weeks | 
| Insulin | Insulin | 4 weeks | 
| HDL Cholesterol | HDL Cholesterol | 4 weeks | 
| Total Cholesterol | Total Cholesterol | 4 weeks | 
| LDL-Cholesterol | LDL-Cholesterol | 4 weeks | 
| Triglycerides | Triglycerides | 4 weeks | 
| Interleukin-6 | Interleukin-6 | 4 weeks | 
| C-Reactive Protein | C-Reactive Protein | 4 weeks | 
| Blood Pressure | Systolic and Diastolic | 4 weeks | 
| Body Composition | Weight measured via scalre, body fat% muscle mass as measured via DEXA | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolome, Pork, Metabolite