Diet InterventionNCT06433115
Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
A study testing Lean (≥90%) Grass-Fed Beef, Lean (≥90%) Grain-Fed Beef and Plant-Based Meat in people with Diet Intervention, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Intervention
- What is being tested?
- Lean (≥90%) Grass-Fed Beef, Lean (≥90%) Grain-Fed Beef and Plant-Based Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65211
Jaapna Dhillon, 573-884-2103, jdhillon@missouri.edu
Jaapna Dhillon, PhD
About this study
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.
Read the 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.
- Conditions
- Diet Intervention
- Being tested
- Lean (≥90%) Grass-Fed Beef, Lean (≥90%) Grain-Fed Beef, Plant-Based Meat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean (≥90%) Grass-Fed BeefOther
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.
Lean (≥90%) Grain-Fed BeefOther
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.
Plant-Based MeatOther
Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
| Study group | Role | What they receive |
|---|---|---|
| Lean (≥90%) Grass-Fed Beef | Experimental | 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. Receives: Other: Lean (≥90%) Grass-Fed Beef |
| Lean (≥90%) Grain-Fed Beef | Experimental | 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. Receives: Other: Lean (≥90%) Grain-Fed Beef |
| Plant-Based Meat | Active comparator | 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. Receives: Other: Plant-Based Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C concentrations
Lipid profile
Measured: Baseline, week 6
Interleukin-6 concentrations
Inflammatory marker
Measured: Baseline, week 6
Gut microbial alpha-diversity
Assessed via16S rRNA sequencing
Measured: Baseline, week 6
Secondary outcomes (22)
HDL-C concentrations
Lipid profile
Measured: Baseline, week 6
Total cholesterol concentrations
Lipid profile
Measured: Baseline, week 6
Triglyceride concentrations
Lipid profile
Measured: Baseline, week 6
Gut microbiome abundance
16S rRNA sequencing
Measured: Baseline, week 6
LPS-binding protein concentration
Intestinal permeability marker
Measured: Baseline, week 6
Glucose concentrations
Blood Glucose
Measured: Baseline, week 6
Insulin concentrations
Insulin
Measured: Baseline, week 6
Body mass
Measured in kg
Measured: Baseline, week 3, and week 6
Fat mass
Fat mass
Measured: Baseline, week 3, and week 6
Fat-free mass
Fat-free mass
Measured: Baseline, week 3, and week 6
Waist circumference
Waist circumference
Measured: Baseline, week 3, and week 6
Hip circumference
Hip Circumference
Measured: Baseline, week 3, and week 6
Thigh circumference
Thigh Circumference
Measured: Baseline, week 3, and week 6
24 hour appetite ratings
24-hour appetite ratings assessed on VAS
Measured: Baseline, week 6
Physical activity scores
Activity assessment using Actigraphs
Measured: Baseline, week 6
Total hours of sleep
Sleep diary
Measured: Baseline, week 6
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS)
Measured: Baseline, week 3, week 6
Acceptance rating of foods
9-point food action rating scale
Measured: Baseline, week 3, week 6
Taste and flavor intensity ratings of foods
Sensory intensity scales
Measured: Baseline
Gene expression levels
Transcriptomics analyses
Measured: Baseline, week 6
Inflammatory marker concentrations
Inflammatory markers
Measured: Baseline, week 6
Healthy eating index score
NCI diet history questionnaire
Measured: Baseline, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start11 Jun 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet InterventionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaapna Dhillon, University of Missouri-Columbia
- Investigators
- Jaapna Dhillon, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433115
- Sponsor's protocol ID
- 2097458
- Other IDs
- 2097458
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
- ClinicalTrials.gov ID
- NCT06433115
- Acronym / sponsor ID
- 2097458
- Conditions
- Diet Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Lean (≥90%) Grass-Fed Beef | Experimental | Other: Lean (≥90%) Grass-Fed BeefThe 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. |
| Lean (≥90%) Grain-Fed Beef | Experimental | Other: Lean (≥90%) Grain-Fed BeefThe 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. |
| Plant-Based Meat | Active comparator | Other: Plant-Based MeatPlant-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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Allergies to foods provided in the study
- Diabetes
- Gastrointestinal disease and/or bariatric surgery
- Uncontrolled hypertension and blood pressure ≥ 180/110
- Illicit drug use
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 |
|---|---|---|
| Lean (≥90%) Grass-Fed BeefThe specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. | Other | Lean (≥90%) Grass-Fed Beef |
| Lean (≥90%) Grain-Fed BeefThe specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. | Other | Lean (≥90%) Grain-Fed Beef |
| Plant-Based MeatPlant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level. | Other | Plant-Based Meat |
Primary outcome
LDL-C concentrations
Time frame: Baseline, week 6
Lipid profile
Interleukin-6 concentrations
Time frame: Baseline, week 6
Inflammatory marker
Gut microbial alpha-diversity
Time frame: Baseline, week 6
Assessed via16S rRNA sequencing
22 secondary outcomes
HDL-C concentrations
Time frame: Baseline, week 6
Total cholesterol concentrations
Time frame: Baseline, week 6
Triglyceride concentrations
Time frame: Baseline, week 6
Gut microbiome abundance
Time frame: Baseline, week 6
LPS-binding protein concentration
Time frame: Baseline, week 6
Glucose concentrations
Time frame: Baseline, week 6
Insulin concentrations
Time frame: Baseline, week 6
Body mass
Time frame: Baseline, week 3, and week 6
Fat mass
Time frame: Baseline, week 3, and week 6
Fat-free mass
Time frame: Baseline, week 3, and week 6
Waist circumference
Time frame: Baseline, week 3, and week 6
Hip circumference
Time frame: Baseline, week 3, and week 6
Thigh circumference
Time frame: Baseline, week 3, and week 6
24 hour appetite ratings
Time frame: Baseline, week 6
Physical activity scores
Time frame: Baseline, week 6
Total hours of sleep
Time frame: Baseline, week 6
Palatability rating of foods
Time frame: Baseline, week 3, week 6
Acceptance rating of foods
Time frame: Baseline, week 3, week 6
Taste and flavor intensity ratings of foods
Time frame: Baseline
Gene expression levels
Time frame: Baseline, week 6
Inflammatory marker concentrations
Time frame: Baseline, week 6
Healthy eating index score
Time frame: Baseline, week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Related trials for Diet Intervention
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
Jaapna Dhillon, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lean (≥90%) Grass-Fed Beef, Lean (≥90%) Grain-Fed Beef and Plant-Based Meat in people with Diet Intervention, run by University of Missouri-Columbia 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaapna Dhillon (573-884-2103, jdhillon@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C concentrations (time frame: Baseline, week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.