NCT05274906

Red and Processed Meat Effects on the Metabolome and Microbiome

Completed NA Results posted Last updated 5 September 2024

What this trial tests

NA trial testing Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat in Controlled Feeding Trial in 23 participants. Completed in 7 February 2023.

Timeline

16 November 2021

Primary endpoint
7 February 2023

7 February 2023

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	23
Start date	16 November 2021
Primary completion	7 February 2023
Estimated completion	7 February 2023
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Controlled Feeding Trial — all drugs for Controlled Feeding Trial →
• Healthy Eating Index — all drugs for Healthy Eating Index →
• Red Meat — all drugs for Red Meat →
• Meat — all drugs for Meat →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

Adults 18 to 50, any sex, with Controlled Feeding Trial or Healthy Eating Index. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome Primary · 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 valu

Hydroxyproline

Group	Value	95% CI
Controlled HEI-2015-M	0.87	± 0.43
Controlled HEI-2015	0.60	± 0.30

1/3-Methylhistidine

Group	Value	95% CI
Controlled HEI-2015-M	3.48	± 4.50
Controlled HEI-2015	5.66	± 7.55

Acetylcarnitine

Group	Value	95% CI
Controlled HEI-2015-M	0.99	± 0.24
Controlled HEI-2015	0.88	± 0.24

Lactose/Trehalose

Group	Value	95% CI
Controlled HEI-2015-M	1.17	± 0.61
Controlled HEI-2015	0.91	± 0.49

N-AcetylGlycine

Group	Value	95% CI
Controlled HEI-2015-M	1.36	± 0.98
Controlled HEI-2015	1.10	± 0.62

Cis-Aconitate

Group	Value	95% CI
Controlled HEI-2015-M	1.05	± 0.33
Controlled HEI-2015	0.89	± 0.34

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

Cholesterol Esther 20:5

Group	Value	95% CI
Controlled HEI-2015-M	1.09	± 0.67
Controlled HEI-2015	0.98	± 0.58

Lysophosphatidylethanolamine 20:3

Group	Value	95% CI
Controlled HEI-2015-M	1.11	± 0.34
Controlled HEI-2015	0.97	± 0.29

Lysophosphatidylethanolamine 22:5

Group	Value	95% CI
Controlled HEI-2015-M	0.89	± 0.29
Controlled HEI-2015	0.80	± 0.18

Phosphatidylcholine 18:0/20:5

Group	Value	95% CI
Controlled HEI-2015-M	1.11	± 1.14
Controlled HEI-2015	0.90	± 0.83

Phosphatidylethanolamine P-18:0/20:3

Group	Value	95% CI
Controlled HEI-2015-M	1.10	± 0.47
Controlled HEI-2015	0.88	± 0.33

Phosphatidylethanolamine P-18:1/18:2

Group	Value	95% CI
Controlled HEI-2015-M	0.82	± 0.24
Controlled HEI-2015	0.65	± 0.20

Phosphatidylethanolamine P-18:0/20:5

Group	Value	95% CI
Controlled HEI-2015-M	0.80	± 0.48
Controlled HEI-2015	0.59	± 0.28

Triacylglycerol 51:2-FA16:0

Group	Value	95% CI
Controlled HEI-2015-M	1.42	± 1.56
Controlled HEI-2015	1.39	± 1.86

Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Primary · 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 decre

Citrate

Group	Value	95% CI
Controlled HEI-2015-M	0.99	± 0.61
Controlled HEI-2015	1.09	± 0.42

Allantoin

Group	Value	95% CI
Controlled HEI-2015-M	1.54	± 0.96
Controlled HEI-2015	2.18	± 1.41

3_hydroxyisovaleric acid

Group	Value	95% CI
Controlled HEI-2015-M	1.16	± 0.70
Controlled HEI-2015	1.24	± 0.41

Glucose

Group	Value	95% CI
Controlled HEI-2015-M	1.10	± 0.63
Controlled HEI-2015	1.22	± 0.45

Creatine

Group	Value	95% CI
Controlled HEI-2015-M	1.21	± 0.80
Controlled HEI-2015	0.90	± 0.42

2_Oxoglutarate

Group	Value	95% CI
Controlled HEI-2015-M	1.17	± 1.31
Controlled HEI-2015	1.11	± 0.36

Choline

Group	Value	95% CI
Controlled HEI-2015-M	1.34	± 1.01
Controlled HEI-2015	1.12	± 1.59

Ascorbic Acid

Group	Value	95% CI
Controlled HEI-2015-M	2.59	± 3.16
Controlled HEI-2015	3.02	± 3.53

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

Group	Value	95% CI
Controlled HEI-2015-M	0.99	± 0.10
Controlled HEI-2015	1.00	± 0.07

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

Butyryl-CoA:acetate CoA transferase (in bacteria species Roseburia)

Group	Value	95% CI
Controlled HEI-2015-M	0.54	± 1.9
Controlled HEI-2015	0.24	± 1.3

Butyryl-CoA:acetate CoA transferase (in bacteria species Eubacteirum rectale)

Group	Value	95% CI
Controlled HEI-2015-M	0.07	± 0.4
Controlled HEI-2015	0.19	± 0.6

Nitrate reductase (in bacteria species Escherichia/Shigella)

Group	Value	95% CI
Controlled HEI-2015-M	0.23	± 0.5
Controlled HEI-2015	0.11	± 0.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.