Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

July 29, 2025 updated by: Jaapna Dhillon, University of Missouri-Columbia
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Recruiting
        • University of Missouri-Columbia
        • Principal Investigator:
          • Jaapna Dhillon, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 18-45 years of age
  • BMI: 18-35 kg/m2
  • Willingness to consume study foods.
  • Willing to comply with study protocol.
  • Consistent diet and activity patterns for 4 weeks
  • Weight stable (≤5 kg change over the last 3 months)
  • Non-smoker >1 year or more

Exclusion Criteria:

  • Allergies to foods provided in the study
  • Diabetes
  • Gastrointestinal disease and/or bariatric surgery
  • Uncontrolled hypertension and blood pressure ≥ 180/110
  • Illicit drug use
  • Recent consumption of antibiotics or probiotics
  • Recent start of medications that affect metabolism or appetite.
  • Recent blood donation
  • Drug therapy for coronary artery disease, peripheral artery disease, congestive - heart failure, or dyslipidemia
  • Pregnant or lactating individuals
  • Taste or smell disorders
  • High consumers of red meat or plant-based meat (≥ 4 times/week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Plant-Based Meat
Plant-based meat (beyond meat product) would be macronutrient matched to the same quantities of meat prescribed for a given energy level. Participants will consume meals for six weeks.
Other: Plant-Based Meat
Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
Experimental: Lean (≥90%) Grass-Fed Beef
The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.
Other: Lean (≥90%) Grass-Fed Beef
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.
Experimental: Lean (≥90%) Grain-Fed Beef
The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.
Other: Lean (≥90%) Grain-Fed Beef
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
LDL-C concentrations
Time Frame: Baseline, week 6
Lipid profile
Baseline, week 6
Interleukin-6 concentrations
Time Frame: Baseline, week 6
Inflammatory marker
Baseline, week 6
Gut microbial alpha-diversity
Time Frame: Baseline, week 6
Assessed via16S rRNA sequencing
Baseline, week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass
Time Frame: Baseline, week 3, and week 6
Measured in kg
Baseline, week 3, and week 6
Palatability rating of foods
Time Frame: Baseline, week 3, week 6
Hedonic general labelled magnitude scale (gLMS)
Baseline, week 3, week 6
Acceptance rating of foods
Time Frame: Baseline, week 3, week 6
9-point food action rating scale
Baseline, week 3, week 6
HDL-C concentrations
Time Frame: Baseline, week 6
Lipid profile
Baseline, week 6
Total cholesterol concentrations
Time Frame: Baseline, week 6
Lipid profile
Baseline, week 6
Triglyceride concentrations
Time Frame: Baseline, week 6
Lipid profile
Baseline, week 6
Gut microbiome abundance
Time Frame: Baseline, week 6
16S rRNA sequencing
Baseline, week 6
LPS-binding protein concentration
Time Frame: Baseline, week 6
Intestinal permeability marker
Baseline, week 6
Glucose concentrations
Time Frame: Baseline, week 6
Blood Glucose
Baseline, week 6
Insulin concentrations
Time Frame: Baseline, week 6
Insulin
Baseline, week 6
Fat mass
Time Frame: Baseline, week 3, and week 6
Fat mass
Baseline, week 3, and week 6
Fat-free mass
Time Frame: Baseline, week 3, and week 6
Fat-free mass
Baseline, week 3, and week 6
Waist circumference
Time Frame: Baseline, week 3, and week 6
Waist circumference
Baseline, week 3, and week 6
Hip circumference
Time Frame: Baseline, week 3, and week 6
Hip Circumference
Baseline, week 3, and week 6
Thigh circumference
Time Frame: Baseline, week 3, and week 6
Thigh Circumference
Baseline, week 3, and week 6
24 hour appetite ratings
Time Frame: Baseline, week 6
24-hour appetite ratings assessed on VAS
Baseline, week 6
Physical activity scores
Time Frame: Baseline, week 6
Activity assessment using Actigraphs
Baseline, week 6
Total hours of sleep
Time Frame: Baseline, week 6
Sleep diary
Baseline, week 6
Taste and flavor intensity ratings of foods
Time Frame: Baseline
Sensory intensity scales
Baseline
Gene expression levels
Time Frame: Baseline, week 6
Transcriptomics analyses
Baseline, week 6
Inflammatory marker concentrations
Time Frame: Baseline, week 6
Inflammatory markers
Baseline, week 6
Healthy eating index score
Time Frame: Baseline, week 6
NCI diet history questionnaire
Baseline, week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolite intensities
Time Frame: Baseline, week 6
Untargeted and targeted metabolomics
Baseline, week 6
Nutrient intakes
Time Frame: Baseline, week 3, week 6
24 hours dietary recall
Baseline, week 3, week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2097458 (Other Identifier: University of Missouri)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Data will be deposited in online repositories

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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