Controlled Feeding TrialNCT05274906

Red and Processed Meat Effects on the Metabolome and Microbiome

A study of Controlled Feeding Trial and Healthy Eating Index, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Controlled Feeding Trial, Healthy Eating Index, Red Meat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 16 Nov 2021to 7 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

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.

Read the 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.

Conditions: Controlled Feeding Trial, Healthy Eating Index, Red Meat, Meat
Being tested: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meatOther
Also called feeding trial, intervention, dietary, HEI-2015
Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)

Study groups in NCT05274906
Study group	Role	What they receive
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) Receives: 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). Receives: Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20217 Feb 2023

First posted11 Mar 2022
Study start16 Nov 2021
Primary completion7 Feb 2023
Study completion7 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Controlled Feeding TrialStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized cross-over
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05274906
Sponsor's protocol ID: RG1121543
Other IDs: 1R21DK128754-01
Status last verified: Aug 2024
First submitted: 18 Feb 2022
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Controlled Feeding Trial trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Red and Processed Meat Effects on the Metabolome and Microbiome
ClinicalTrials.gov ID: NCT05274906
Acronym / sponsor ID: RG1121543
Conditions: Controlled Feeding Trial, Healthy Eating Index, Red Meat, Meat
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 16 Nov 2021 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 11 Mar 2022 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized cross-over

Arm	Type	Receives
Controlled HEI-2015-M diet, followed by controlled HEI-2015 diet.	Experimental	Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meatParticipants 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 controlled HEI-2015-M diet.	Experimental	Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meatParticipants 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).

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meatAlso: feeding trial, intervention, dietary, HEI-2015Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)	Other	Controlled HEI-2015 diet, followed by controlled HEI-2015-M diet., Controlled HEI-2015-M diet, followed by controlled HEI-2015 diet.

Primary outcome

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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Controlled HEI-2015-M Diet, Followed by Controlled HEI-2015 Diet.	12	10
Controlled HEI-2015 Diet, Followed by Contrilled HEI-2015-M Diet.	11	10

Primary outcome: Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome

Time frame: Day 21. Mean (Standard Deviation). Unit: ratio of day 21 to day 0

Measure	Controlled HEI-2015-M n = 20	Controlled HEI-2015 n = 20
Hydroxyproline	0.87 (0.43)	0.60 (0.30)
1/3-Methylhistidine	3.48 (4.50)	5.66 (7.55)
Acetylcarnitine	0.99 (0.24)	0.88 (0.24)
Lactose/Trehalose	1.17 (0.61)	0.91 (0.49)
N-AcetylGlycine	1.36 (0.98)	1.10 (0.62)
Cis-Aconitate	1.05 (0.33)	0.89 (0.34)

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

Primary outcome: Test the Effects of Red and Processed Meat on Lipid Biomarkers of the Blood Metabolome

Time frame: Day 21. Mean (Standard Deviation). Unit: ratio of day 21 to day 0

Measure	Controlled HEI-2015-M n = 20	Controlled HEI-2015 n = 20
Cholesterol Esther 20:5	1.09 (0.67)	0.98 (0.58)
Lysophosphatidylethanolamine 20:3	1.11 (0.34)	0.97 (0.29)
Lysophosphatidylethanolamine 22:5	0.89 (0.29)	0.80 (0.18)
Phosphatidylcholine 18:0/20:5	1.11 (1.14)	0.90 (0.83)
Phosphatidylethanolamine P-18:0/20:3	1.10 (0.47)	0.88 (0.33)
Phosphatidylethanolamine P-18:1/18:2	0.82 (0.24)	0.65 (0.20)
Phosphatidylethanolamine P-18:0/20:5	0.80 (0.48)	0.59 (0.28)
Triacylglycerol 51:2-FA16:0	1.42 (1.56)	1.39 (1.86)

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

Primary outcome: Test the Effects of Red and Processed Meat on Biomarkers on the Urine Metabolome

Time frame: Day 21. Mean (Standard Deviation). Unit: ratio of day 21 to day 0

Measure	Controlled HEI-2015-M n = 20	Controlled HEI-2015 n = 20
Citrate	0.99 (0.61)	1.09 (0.42)
Allantoin	1.54 (0.96)	2.18 (1.41)
3_hydroxyisovaleric acid	1.16 (0.70)	1.24 (0.41)
Glucose	1.10 (0.63)	1.22 (0.45)
Creatine	1.21 (0.80)	0.90 (0.42)
2_Oxoglutarate	1.17 (1.31)	1.11 (0.36)
Choline	1.34 (1.01)	1.12 (1.59)
Ascorbic Acid	2.59 (3.16)	3.02 (3.53)

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

Primary outcome: Test the Effects of Red and Processed Meat on Gut Microbiome

Time frame: Day 21. Mean (Standard Deviation). Unit: score on a scale

Measure	Controlled HEI-2015-M n = 20	Controlled HEI-2015 n = 20
Value	0.99 (0.10)	1.00 (0.07)

Adverse events

Time frame: From start of intervention to ending of intervention: up to 9 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Controlled HEI-2015-M Diet	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Controlled HEI-2015 Diet	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marian L. Neuhouser, PhD, RD principal investigator

Fred Hutchinson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Controlled Feeding Trial and Healthy Eating Index, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test the Effects of Red and Processed Meat on Aqueous Biomarkers of the Blood Metabolome (time frame: Day 21). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05274906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.