## Protocol Section
### Identification Module
**NCT ID:** NCT06433115

**Brief Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

**Official Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

#### Organization Study ID Info
**ID:** 2097458
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
#### Secondary ID Infos
**Domain:** University of Missouri
**ID:** 2097458
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Missouri-Columbia

#### Responsible Party

**Investigator Affiliation:** University of Missouri-Columbia

**Investigator Full Name:** Jaapna Dhillon

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Diet Intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel Assignment

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Single Blind

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Lean (93%) Grass-Fed Beef

**Label:** Lean (93%) Grass-Fed Beef

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Lean (93%) Grain-Fed Beef

**Label:** Lean (93%) Grain-Fed Beef

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Other: Plant-Based Meat

**Label:** Plant-Based Meat

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lean (93%) Grass-Fed Beef

**Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.

**Name:** Lean (93%) Grass-Fed Beef

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Lean (93%) Grain-Fed Beef

**Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.

**Name:** Lean (93%) Grain-Fed Beef

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Plant-Based Meat

**Description:** Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.

**Name:** Plant-Based Meat

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Untargeted and targeted metabolomics

**Measure:** Metabolite intensities

**Time Frame:** Baseline, week 6

**Description:** 24 hours dietary recall

**Measure:** Nutrient intakes

**Time Frame:** Baseline, week 3, week 6

#### Primary Outcomes

**Description:** Lipid profile

**Measure:** LDL-C concentrations

**Time Frame:** Baseline, week 6

**Description:** Inflammatory marker

**Measure:** Interleukin-6 concentrations

**Time Frame:** Baseline, week 6

**Description:** Assessed via16S rRNA sequencing

**Measure:** Gut microbial alpha-diversity

**Time Frame:** Baseline, week 6

#### Secondary Outcomes

**Description:** Lipid profile

**Measure:** HDL-C concentrations

**Time Frame:** Baseline, week 6

**Description:** Lipid profile

**Measure:** Total cholesterol concentrations

**Time Frame:** Baseline, week 6

**Description:** Lipid profile

**Measure:** Triglyceride concentrations

**Time Frame:** Baseline, week 6

**Description:** 16S rRNA sequencing

**Measure:** Gut microbiome abundance

**Time Frame:** Baseline, week 6

**Description:** Intestinal permeability marker

**Measure:** LPS-binding protein concentration

**Time Frame:** Baseline, week 6

**Description:** Blood Glucose

**Measure:** Glucose concentrations

**Time Frame:** Baseline, week 6

**Description:** Insulin

**Measure:** Insulin concentrations

**Time Frame:** Baseline, week 6

**Description:** Measured in kg

**Measure:** Body mass

**Time Frame:** Baseline, week 3, and week 6

**Description:** Fat mass

**Measure:** Fat mass

**Time Frame:** Baseline, week 3, and week 6

**Description:** Fat-free mass

**Measure:** Fat-free mass

**Time Frame:** Baseline, week 3, and week 6

**Description:** Waist circumference

**Measure:** Waist circumference

**Time Frame:** Baseline, week 3, and week 6

**Description:** Hip Circumference

**Measure:** Hip circumference

**Time Frame:** Baseline, week 3, and week 6

**Description:** Thigh Circumference

**Measure:** Thigh circumference

**Time Frame:** Baseline, week 3, and week 6

**Description:** 24-hour appetite ratings assessed on VAS

**Measure:** 24 hour appetite ratings

**Time Frame:** Baseline, week 6

**Description:** Activity assessment using Actigraphs

**Measure:** Physical activity scores

**Time Frame:** Baseline, week 6

**Description:** Sleep diary

**Measure:** Total hours of sleep

**Time Frame:** Baseline, week 6

**Description:** Hedonic general labelled magnitude scale (gLMS)

**Measure:** Palatability rating of foods

**Time Frame:** Baseline, week 3, week 6

**Description:** 9-point food action rating scale

**Measure:** Acceptance rating of foods

**Time Frame:** Baseline, week 3, week 6

**Description:** Sensory intensity scales

**Measure:** Taste and flavor intensity ratings of foods

**Time Frame:** Baseline

**Description:** Transcriptomics analyses

**Measure:** Gene expression levels

**Time Frame:** Baseline, week 6

**Description:** Inflammatory markers

**Measure:** Inflammatory marker concentrations

**Time Frame:** Baseline, week 6

**Description:** NCI diet history questionnaire

**Measure:** Healthy eating index score

**Time Frame:** Baseline, week 6

### Eligibility Module

**Eligibility Criteria:** 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
* Recent start of medications that affect metabolism or appetite.
* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
* Pregnant or lactating individuals
* Taste or smell disorders

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jdhillon@missouri.edu

**Name:** Jaapna Dhillon

**Phone:** 573-884-2103

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Columbia

**Contacts:**

***Contact 1:***

- **Email:** jdhillon@missouri.edu

- **Name:** Jaapna Dhillon

- **Phone:** 573-884-2103

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jaapna Dhillon, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Missouri-Columbia

**State:** Missouri

**Zip:** 65211

#### Overall Officials

**Official 1:**

**Affiliation:** University of Missouri-Columbia

**Name:** Jaapna Dhillon, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Data will be deposited in online repositories

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

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Immediately following publication. No end date.

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
