Red and Processed Meat Effects on the Metabolome and Microbiome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2023-02-07

Brief Summary

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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.

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Detailed Description

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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

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Controlled Feeding Trial Healthy Eating Index Red Meat Meat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)

Controlled HEI-2015 diet, followed by controlled 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).

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)

Interventions

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

Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)

Intervention Type OTHER

Other Intervention Names

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feeding trial, intervention, dietary, HEI-2015

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes