Actively Recruiting
A Randomized Study Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Dietary Pattern on Inflammation and Metabolic Outcomes in Adults with Metabolic Syndrome or Pre-Diabetes
Led by National Cattlemen's Beef Association, a contractor to the Beef Checkoff · Updated on 2026-05-04
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Lead Sponsor
N
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with metabolic syndrome and/or pre-diabetes to compare how two different healthy diets affect inflammation and other measures of metabolic health. The study aims to evaluate whether a beef-focused diet influences blood sugar control, inflammation, cholesterol levels, and quality of life compared to a healthy U.S.-style dietary pattern based on USDA guidelines. This is a randomized trial involving adults between 18 and 74 years old with metabolic risk factors. Participants will follow one of two diets for five weeks. One group will eat a healthy U.S.-style diet that includes balanced portions of fruits, vegetables, whole grains, lean proteins, and low-fat dairy following USDA MyPlate guidelines. The other group will follow a healthy beef-centric diet where 70% of daily calories come from beef, with the rest from other proteins, fats, and low-carbohydrate fruits and vegetables, excluding grains. Both diets are designed to be nutritious but differ in protein sources and carbohydrate content. During the study, participants will be assessed for inflammation levels, blood pressure, body weight, glucose control, lipid profiles, and quality of life. Evaluations will take place from the start to the end of the five-week diet period. The study also monitors participants' adherence to the diets and collects data on metabolic health outcomes to understand the effects of these dietary patterns on pre-diabetic and metabolic syndrome adults.
CONDITIONS
Brief Title
Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Diet on Metabolic Health Outcomes in Pre-Diabetic Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be aged 18 to 74 years at the time of consent
- Have a body mass index (BMI) between 23.0 and 39.9 kg/m2
- Be in generally good health as judged by the investigator
- Have blood hs-CRP levels of 2.0 mg/L or higher at screening
- Have pre-diabetes (HbA1c 5.7-6.4%) and/or metabolic syndrome with at least 3 of 5 specific metabolic risk factors
- Report low to moderate physical activity levels at screening
- Regularly consume meat-based protein including beef
- Not have used nicotine products more than 3 times in the past 3 months and be willing to abstain during the study
- Have maintained stable body weight (±10%) for at least 6 months prior to screening
- Be willing and able to follow all aspects and restrictions of the assigned study diet
- Maintain consistent diet, medication, supplement use, and lifestyle for 3 months before screening and agree to maintain them during the study
- Agree to restrictions on treatments and lifestyle during the study
- Agree to avoid pregnancy during the study if of childbearing potential
- Be able to understand, consent, and comply with study procedures
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the study
- Allergic or intolerant to any study diet components or continuous glucose monitor sensor
- Have followed a ketogenic, Mediterranean, low-carbohydrate, vegetarian, vegan, or other special diet in the 3 months prior to screening
- Diagnosed with Type I or II diabetes or thyroid disease
- Have blood pressure of 160/100 mmHg or higher
- Have a history or current diagnosis of eating disorders
- Have symptoms of acute infection within 7 days before screening
- Have medical conditions affecting nutrient absorption or metabolism
- Have history of gallbladder disease, gout, or kidney stones
- Have history of heart, kidney, liver, immune disorders, or immunocompromised status
- Have history of cancer (except certain skin or cervical cancers) with recovery less than 5 years ago
- Receiving treatment or hospitalization for psychiatric disorders in last 12 months
- Recent major surgery within 3 months or planned during the study
- History of alcohol or substance abuse within 12 months
- Participation in another study with active products within 28 days or longer if effects persist
- Living with another participant currently enrolled in this study
- Any other medical or medication condition judged by investigator to interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 weeks
Participants follow either a healthy beef-centric diet or a healthy U.S.-style dietary pattern to assess effects on metabolic health outcomes.
Trial Site Locations
Total: 1 location
1
Apex Trials
Guelph, Ontario - on, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Adam Kuttenkeuler
S
Stephanie Recker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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