Red and Processed Meat Effects on the Metabolome and Microbiome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Controlled HEI-2015 diet with red and processed meat
|
Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat
Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)
Other Names:
|
| Experimental: Controlled HEI-2015 diet without red and processed meat
|
Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat
Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Test the effects of red and processed meat on biomarkers in the blood metabolome [3 weeks]
Plasma metabolomics will be evaluated via LC/MS-MS and NMR to identify metabolomic markers after the first diet period.
- Test the effects of red and processed meat on biomarkers in the urine metabolome [3 weeks]
Effects of the intervention on urine metabolomic biomarkers will be evaluated via NMR.
- Test the effects of red and processed meat on gut microbiome [3 weeks]
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.
- Test the effects of red and processed meat on fecal bacterial functional genes [3 weeks]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Marian L. Neuhouser, PhD, RD, Fred Hutchinson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1121543
- 1R21DK128754-01