Red and Processed Meat Effects on the Metabolome and Microbiome

Study Overview
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Brief Summary
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This controlled feeding trial will identify biomarkers in the metabolome and microbiome that may differ when consuming a healthy diet with or without red and processed meat.

Detailed Description
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This is a randomized cross-over feeding trial to test whether red and processed meat consumption, in the context of a controlled diet based on HEI-2015, will cause shifts in the metabolome and the microbiome compared to a controlled HEI-2015 diet with no red or processed meat. Twenty healthy adult volunteers will consume two diets in random order: 1) Diet A is based on the Healthy Eating Index-2015 (HEI-2015) and includes no red or processed meat; 2) Diet B is based on the Healthy Eating Index-2015 and includes red and processed meat (HEI-2015-M) as some of the protein sources. Both diet periods last 21 days and an approximately 21-day washout period occurs between diets.

Official Title
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Red and Processed Meat Effects on the Metabolome and Microbiome

Conditions
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Controlled Feeding Trial, Healthy Eating Index, Red Meat, Meat

Intervention / Treatment
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* Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult, 18-50 years of age, able to read, speak, and understand English, and willing to come to the Fred Hutchinson Cancer Research Center campus twice weekly during study Exclusion Criteria: known allergy to red or processed meat, vegetarian or vegan, any religious or personal reason(s) to avoid red and processed meat, pregnant an/or exclusively breastfeeding, and/or alcohol or recreational drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross-over
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controlled HEI-2015 diet with red and processed meat<br> | Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat<br>* Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)<br>* Other names: feeding trial, intervention, dietary, HEI-2015;|
| Experimental: Controlled HEI-2015 diet without red and processed meat<br> | Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat<br>* Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)<br>* Other names: feeding trial, intervention, dietary, HEI-2015;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the effects of red and processed meat on biomarkers in the blood metabolome | Plasma metabolomics will be evaluated via LC/MS-MS and NMR to identify metabolomic markers after the first diet period. | 3 weeks | 
| Test the effects of red and processed meat on biomarkers in the urine metabolome | Effects of the intervention on urine metabolomic biomarkers will be evaluated via NMR. | 3 weeks | 
| Test the effects of red and processed meat on gut microbiome | Effect of the intervention on alpha and beta diversity of the fecal microbial community structure will be evaluated by 16s sequencing of fecal bacterial DNA. | 3 weeks | 
| Test the effects of red and processed meat on fecal bacterial functional genes | Effect of the intervention on bacterial functional genes (e.g., butyrate kinase. Nitrate reductase) in the fecal microbiome will be evaluated by digital droplet PCR. | 3 weeks |