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Completed

NCT Number: NCT05274906

Red and Processed Meat Effects on the Metabolome and Microbiome

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.

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Key information

Conditions

Controlled Feeding Trial Healthy Eating Index Meat Red Meat

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)

Other names: feeding trial, intervention, dietary, HEI-2015

Primary outcomes

  1. Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome

    Time frame: Day 21

    Plasma aqueous metabolomics were evaluated via Liquid Chromatography/Mass Spectrometry (LC/MS). Data are relative concentrations - the concentration of a specified biomarker is relative to the concentration of all other biomarkers. Data are reported as the mean ratio of relative concentration on day 21 compared to day 0 [(relative concentration day 21)/(relative concentration day 0)]. A value above 1.0 indicates that the relative concentration of the metabolite increased from baseline at the end of the diet, whereas a value below 1.0 indicates the relative concentration decreased, and a value of 1.0 indicates no change from baseline.

  2. Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome

    Time frame: Day 21

    Plasma lipid metabolomics were evaluated via Liquid Chromatography/Mass Spectrometry (LC/MS). Data are absolute concentrations. Data are reported as the mean ratio of relative concentration on day 21 compared to day 0 [(relative concentration day 21)/(relative concentration day 0)]. A value above 1.0 indicates that the relative concentration of the metabolite increased from baseline at the end of the diet, whereas a value below 1.0 indicates the relative concentration decreased, and a value of 1.0 indicates no change from baseline.

  3. Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome

    Time frame: Day 21

    Effects of the intervention on urine metabolomic biomarkers were evaluated via Nuclear Magnetic Resonance (NMR). Urine metabolites are absolute concentrations standardized (as a ratio) to trimethyl-silylpropionic-2,2,3,3-d4 acid sodium salt (TSP). Data are reported as the mean ratio of relative concentration on day 21 compared to day 0 [(relative concentration day 21)/(relative concentration day 0)]. A value above 1.0 indicates that the relative concentration of the metabolite increased from baseline at the end of the diet, whereas a value below 1.0 indicates the relative concentration decreased, and a value of 1.0 indicates no change from baseline.

  4. Test the Effects of Red and Processed Meat on Gut Microbiome

    Time frame: Day 21

    Shannon's Diversity Index (SDI) was used as a measure of species diversity, calculated as the sum of -p/ln(p), where p is the proportion of the sample made up of each OTU using the QIIME2 shannon_pd plugin. Sampled 16S rRNA sequences were organized into 'amplicon sequence variants' (ASVs), ASVs were filtered by abundance with a threshold of 1e - 5. This measure is a unitless scale proportion ranging from zero to infinity. Zero indicates a completely homogenous sample, and higher scores indicate greater species diversity.

  5. Test the Effects of Red and Processed Meat on Fecal Bacterial Functional Genes

    Time frame: Day 21

    Fecal bacterial functional genes were evaluated via digital droplet PCR. Data are reported as the difference between day 21 and day 0 (calculated as day 21 - day 0) of each diet in the relative abundance (calculated as gene counts/16s rRNA gene counts) of fecal bacterial functional genes. A value that is positive indicates that the relative abundance increased from baseline to the end of the diet, whereas a negative value indicates the relative abundance decreased.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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