Trial Outcomes & Findings for Red and Processed Meat Effects on the Metabolome and Microbiome (NCT NCT05274906)

Last Updated: 2024-09-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Day 21

Results posted on

2024-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Controlled HEI-2015-M Diet, Followed by Controlled HEI-2015 Diet. 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)	Controlled HEI-2015 Diet, Followed by Contrilled HEI-2015-M Diet. 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).
Overall Study STARTED	12	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Controlled HEI-2015-M Diet, Followed by Controlled HEI-2015 Diet. 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)	Controlled HEI-2015 Diet, Followed by Contrilled HEI-2015-M Diet. 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).
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Red and Processed Meat Effects on the Metabolome and Microbiome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controlled HEI-2015-M Diet, Followed by Controlled HEI-2015 Diet. n=12 Participants 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)	Controlled HEI-2015 Diet, Followed by Contrilled HEI-2015-M Diet. n=11 Participants 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).	Total n=23 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years n=5 Participants	34 years n=7 Participants	34 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 21

Population: Cross-over design; each participant completed each arm in random order

Outcome measures

Outcome measures
Measure	Controlled HEI-2015-M n=20 Participants Controlled HEI-2015 diet with red and processed meat.	Controlled HEI-2015 n=20 Participants Controlled HEI-2015 diet without red and processed meat
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome Hydroxyproline	0.87 ratio of day 21 to day 0 Standard Deviation 0.43	0.60 ratio of day 21 to day 0 Standard Deviation 0.30
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome 1/3-Methylhistidine	3.48 ratio of day 21 to day 0 Standard Deviation 4.50	5.66 ratio of day 21 to day 0 Standard Deviation 7.55
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome Acetylcarnitine	0.99 ratio of day 21 to day 0 Standard Deviation 0.24	0.88 ratio of day 21 to day 0 Standard Deviation 0.24
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome Lactose/Trehalose	1.17 ratio of day 21 to day 0 Standard Deviation 0.61	0.91 ratio of day 21 to day 0 Standard Deviation 0.49
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome N-AcetylGlycine	1.36 ratio of day 21 to day 0 Standard Deviation 0.98	1.10 ratio of day 21 to day 0 Standard Deviation 0.62
Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome Cis-Aconitate	1.05 ratio of day 21 to day 0 Standard Deviation 0.33	0.89 ratio of day 21 to day 0 Standard Deviation 0.34

PRIMARY outcome

Timeframe: Day 21

Population: Cross-over design; each participant completed each arm in random order

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.

Outcome measures

PRIMARY outcome

Timeframe: Day 21

Population: Cross-over design; each participant completed each arm in random order

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.

Outcome measures

Outcome measures
Measure	Controlled HEI-2015-M n=20 Participants Controlled HEI-2015 diet with red and processed meat.	Controlled HEI-2015 n=20 Participants Controlled HEI-2015 diet without red and processed meat
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Citrate	0.99 ratio of day 21 to day 0 Standard Deviation 0.61	1.09 ratio of day 21 to day 0 Standard Deviation 0.42
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Allantoin	1.54 ratio of day 21 to day 0 Standard Deviation 0.96	2.18 ratio of day 21 to day 0 Standard Deviation 1.41
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome 3_hydroxyisovaleric acid	1.16 ratio of day 21 to day 0 Standard Deviation 0.70	1.24 ratio of day 21 to day 0 Standard Deviation 0.41
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Glucose	1.10 ratio of day 21 to day 0 Standard Deviation 0.63	1.22 ratio of day 21 to day 0 Standard Deviation 0.45
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Creatine	1.21 ratio of day 21 to day 0 Standard Deviation 0.80	0.90 ratio of day 21 to day 0 Standard Deviation 0.42
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome 2_Oxoglutarate	1.17 ratio of day 21 to day 0 Standard Deviation 1.31	1.11 ratio of day 21 to day 0 Standard Deviation 0.36
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Choline	1.34 ratio of day 21 to day 0 Standard Deviation 1.01	1.12 ratio of day 21 to day 0 Standard Deviation 1.59
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Ascorbic Acid	2.59 ratio of day 21 to day 0 Standard Deviation 3.16	3.02 ratio of day 21 to day 0 Standard Deviation 3.53
Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome Propanediol	2.60 ratio of day 21 to day 0 Standard Deviation 4.62	3.43 ratio of day 21 to day 0 Standard Deviation 4.91

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controlled HEI-2015-M n=20 Participants Controlled HEI-2015 diet with red and processed meat.	Controlled HEI-2015 n=20 Participants Controlled HEI-2015 diet without red and processed meat
Test the Effects of Red and Processed Meat on Gut Microbiome	0.99 score on a scale Standard Deviation 0.10	1.00 score on a scale Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Controlled HEI-2015-M n=20 Participants Controlled HEI-2015 diet with red and processed meat.	Controlled HEI-2015 n=20 Participants Controlled HEI-2015 diet without red and processed meat
Test the Effects of Red and Processed Meat on Fecal Bacterial Functional Genes Butyryl-CoA:acetate CoA transferase (in bacteria species Roseburia)	0.54 proportion of gene counts Standard Deviation 1.9	0.24 proportion of gene counts Standard Deviation 1.3
Test the Effects of Red and Processed Meat on Fecal Bacterial Functional Genes Butyryl-CoA:acetate CoA transferase (in bacteria species Eubacteirum rectale)	0.07 proportion of gene counts Standard Deviation 0.4	0.19 proportion of gene counts Standard Deviation 0.6
Test the Effects of Red and Processed Meat on Fecal Bacterial Functional Genes Nitrate reductase (in bacteria species Escherichia/Shigella)	0.23 proportion of gene counts Standard Deviation 0.5	0.11 proportion of gene counts Standard Deviation 0.3

Adverse Events

Controlled HEI-2015-M Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controlled HEI-2015 Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marian L. Neuhouser, Principal Investigator

Fred Hutchinson Cancer Center

Phone: 206-667-4797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Controlled HEI-2015-M n=20 Participants Controlled HEI-2015 diet with red and processed meat.	Controlled HEI-2015 n=20 Participants Controlled HEI-2015 diet without red and processed meat
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Cholesterol Esther 20:5	1.09 ratio of day 21 to day 0 Standard Deviation 0.67	0.98 ratio of day 21 to day 0 Standard Deviation 0.58
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Lysophosphatidylethanolamine 20:3	1.11 ratio of day 21 to day 0 Standard Deviation 0.34	0.97 ratio of day 21 to day 0 Standard Deviation 0.29
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Lysophosphatidylethanolamine 22:5	0.89 ratio of day 21 to day 0 Standard Deviation 0.29	0.80 ratio of day 21 to day 0 Standard Deviation 0.18
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylcholine 18:0/20:5	1.11 ratio of day 21 to day 0 Standard Deviation 1.14	0.90 ratio of day 21 to day 0 Standard Deviation 0.83
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/20:3	1.10 ratio of day 21 to day 0 Standard Deviation 0.47	0.88 ratio of day 21 to day 0 Standard Deviation 0.33
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:1/18:2	0.82 ratio of day 21 to day 0 Standard Deviation 0.24	0.65 ratio of day 21 to day 0 Standard Deviation 0.20
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/20:5	0.80 ratio of day 21 to day 0 Standard Deviation 0.48	0.59 ratio of day 21 to day 0 Standard Deviation 0.28
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Triacylglycerol 51:2-FA16:0	1.42 ratio of day 21 to day 0 Standard Deviation 1.56	1.39 ratio of day 21 to day 0 Standard Deviation 1.86
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Triacylglycerol 54:7-FA22:5	1.37 ratio of day 21 to day 0 Standard Deviation 0.75	1.62 ratio of day 21 to day 0 Standard Deviation 0.88
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Cholesterol Esther 18:3	1.00 ratio of day 21 to day 0 Standard Deviation 0.31	0.90 ratio of day 21 to day 0 Standard Deviation 0.28
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Ceramides d18:1(24:0)	0.90 ratio of day 21 to day 0 Standard Deviation 0.18	0.84 ratio of day 21 to day 0 Standard Deviation 0.20
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Diacylglycerol 18:2/20:4	1.15 ratio of day 21 to day 0 Standard Deviation 0.19	1.31 ratio of day 21 to day 0 Standard Deviation 0.66
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Hexosylceramides d18:1(22:0)	0.88 ratio of day 21 to day 0 Standard Deviation 0.14	0.82 ratio of day 21 to day 0 Standard Deviation 0.13
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Lysophosphatidylcholine (19:0)	1.13 ratio of day 21 to day 0 Standard Deviation 0.30	1.05 ratio of day 21 to day 0 Standard Deviation 0.31
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Lysophosphatidylethanolamine 20:2	0.79 ratio of day 21 to day 0 Standard Deviation 0.22	0.68 ratio of day 21 to day 0 Standard Deviation 0.19
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylcholine 16:0/20:5	1.06 ratio of day 21 to day 0 Standard Deviation 0.83	0.89 ratio of day 21 to day 0 Standard Deviation 0.57
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylcholine 18:0/20:3	1.12 ratio of day 21 to day 0 Standard Deviation 0.41	1.01 ratio of day 21 to day 0 Standard Deviation 0.39
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylcholine 18:2/20:3	1.10 ratio of day 21 to day 0 Standard Deviation 0.33	0.94 ratio of day 21 to day 0 Standard Deviation 0.29
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine O-16:0/22:6	1.13 ratio of day 21 to day 0 Standard Deviation 0.51	0.94 ratio of day 21 to day 0 Standard Deviation 0.37
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-16:0/18:1	0.93 ratio of day 21 to day 0 Standard Deviation 0.28	0.83 ratio of day 21 to day 0 Standard Deviation 0.21
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-16:0/18:2	0.88 ratio of day 21 to day 0 Standard Deviation 0.31	0.77 ratio of day 21 to day 0 Standard Deviation 0.23
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-16:0/22:5	0.90 ratio of day 21 to day 0 Standard Deviation 0.25	0.79 ratio of day 21 to day 0 Standard Deviation 0.21
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/18:1	0.84 ratio of day 21 to day 0 Standard Deviation 0.23	0.72 ratio of day 21 to day 0 Standard Deviation 0.17
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/18:2	0.82 ratio of day 21 to day 0 Standard Deviation 0.27	0.67 ratio of day 21 to day 0 Standard Deviation 0.19
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/20:4	1.10 ratio of day 21 to day 0 Standard Deviation 0.44	0.97 ratio of day 21 to day 0 Standard Deviation 0.37
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:0/22:5	0.89 ratio of day 21 to day 0 Standard Deviation 0.28	0.78 ratio of day 21 to day 0 Standard Deviation 0.29
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:1/18:1	0.84 ratio of day 21 to day 0 Standard Deviation 0.27	0.68 ratio of day 21 to day 0 Standard Deviation 0.20
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphatidylethanolamine P-18:1/20:4	1.11 ratio of day 21 to day 0 Standard Deviation 0.44	0.95 ratio of day 21 to day 0 Standard Deviation 0.35
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Phosphoinositides 18:0/18:1	0.93 ratio of day 21 to day 0 Standard Deviation 0.37	0.82 ratio of day 21 to day 0 Standard Deviation 0.30
Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome Triacylglycerol 54:8-FA22:6	1.36 ratio of day 21 to day 0 Standard Deviation 0.74	1.78 ratio of day 21 to day 0 Standard Deviation 1.14