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Red and Processed Meat Effects on the Metabolome and Microbiome

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Controlled Feeding Trial
Meat
Healthy Eating Index
Red Meat

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05274906
1R21DK128754-01 (U.S. NIH Grant/Contract)
RG1121543

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

23 participants in 2 patient groups

Controlled HEI-2015-M diet, followed by controlled HEI-2015 diet.
Experimental group
Description:
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)
Treatment:
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 group
Description:
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).
Treatment:
Other: Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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