Red and Processed Meat Effects on the Metabolome and Microbiome

NCT05274906 | Completed Results

• 2 other identifiers: RG11215431R21DK128754-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Controlled Feeding Trial; Healthy Eating Index; Red Meat; Meat

Outcome Measures

Primary Outcomes (5)

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

  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.

  Day 21

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

  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.

  Day 21

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

  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.

  Day 21

• Test the Effects of Red and Processed Meat on Gut Microbiome

  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.

  Day 21

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

  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.

  Day 21

Study Arms (2)

Controlled HEI-2015-M diet, followed by controlled HEI-2015 diet.

EXPERIMENTAL

Participants first complete a 21-day controlled HEI-2015 diet with red and processed meat (HEI-2015-M). After a washout period of 1 week or longer, participants then complete the same 21-day controlled HEI-2015 diet without red and processed meat (HEI-2015)

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

Controlled HEI-2015 diet, followed by controlled HEI-2015-M diet.

EXPERIMENTAL

Participants first complete a 21-day controlled HEI-2015 diet without red and processed meat (HEI-2015). After a washout period of 1 week or longer, participants then complete the same 21-day controlled HEI-2015 diet with red and processed meat (HEI-2015-M).

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

Interventions

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)

Also known as: feeding trial, intervention, dietary, HEI-2015

Controlled HEI-2015 diet, followed by controlled HEI-2015-M diet.; Controlled HEI-2015-M diet, followed by controlled HEI-2015 diet.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Random Allocation; Diet; Dyrk Kinases; Methods

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Marian L. Neuhouser, Principal Investigator
• Organization: Fred Hutchinson Cancer Center

mneuhous@fredhutch.org

206-667-4797

Study Officials

• Marian L. Neuhouser, PhD, RD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Member, Program Head, Cancer Prevention Program

Model Details: Randomized cross-over

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 11, 2022
• Study Start: November 16, 2021
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)