Red and Processed Meat Effects on the Metabolome and Microbiome

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