Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

University of Missouri (MU)

Status: Enrolling

Conditions: Diet Intervention

Treatments: Other: Lean (≥90%) Grain-Fed Beef; Other: Plant-Based Meat; Other: Lean (≥90%) Grass-Fed Beef

Study type: Interventional

Funder types: Other

Identifiers

NCT06433115

2097458 (Other Identifier)

Details and patient eligibility

About

This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

Lean (≥90%) Grass-Fed Beef

Experimental group

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.

Treatment:

Other: Lean (≥90%) Grass-Fed Beef

Lean (≥90%) Grain-Fed Beef

Experimental group

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.

Treatment:

Other: Lean (≥90%) Grain-Fed Beef

Plant-Based Meat

Active Comparator group

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.

Treatment:

Other: Plant-Based Meat