Actively Recruiting
Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Diet on Metabolic Health Outcomes in Pre-Diabetic Adults
Led by National Cattlemen's Beef Association, a contractor to the Beef Checkoff · Updated on 2026-05-04
56
Participants Needed
1
Research Sites
29 weeks
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
This randomized study will be conducted to compare the effect of a healthy beef-centric diet to a healthy U.S.-style dietary pattern on inflammation and other metabolic health outcomes in a metabolic syndrome and/or pre-diabetic population.
CONDITIONS
Official 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...
- Age between 18 and 74 years at consent
- Body mass index (BMI) between 23.0 and 39.9 kg/m2
- Generally good health as determined by the investigator
- Blood hs-CRP levels of 2.0 mg/L or higher at screening
- Diagnosed with pre-diabetes (HbA1c 5.7-6.4%) and/or metabolic syndrome with at least 3 of 5 metabolic criteria including waist circumference, triglycerides, HDL cholesterol, fasting glucose, or blood pressure
- Low to moderate physical activity levels as classified by IPAQ-SF or IPAQ-E at screening
- Regularly consume meat-based protein including beef
- Use of nicotine products limited to 3 or fewer times in past 3 months and willing to abstain from 14 days before Visit 2 until last procedure
- Stable body weight within +/- 10% for at least 6 months prior to screening
- Willing and able to follow all study dietary interventions and restrictions
- Maintain consistent dietary habits, medications, supplements, and lifestyle for 3 months before screening and throughout study
- Agree to restrictions on concomitant treatments and lifestyle
- Agree to avoid pregnancy during study if of childbearing potential using contraception
- Willing and able to provide informed consent, understand questionnaires, and comply with study procedures
You will not qualify if you...
- Lactating, pregnant, or planning pregnancy during study confirmed by positive pregnancy test at Visit 2
- Allergy or intolerance to study diet components or CGM sensor
- Following ketogenic, Mediterranean, low-carb, vegetarian, vegan, or special diet within 3 months prior to screening
- Diagnosed with Type I or II diabetes or thyroid disease
- Blood pressure ≥160 systolic or ≥100 diastolic mmHg
- History or current diagnosis of eating disorders (anorexia, bulimia)
- Symptoms of acute infection within 7 days before screening
- Medical conditions affecting nutrient absorption or metabolism (e.g., Crohn's, pancreatitis)
- History of gallbladder disease, gout, or kidney stones
- History of cardiovascular, renal, hepatic, immune disorders or immunocompromised status
- History of cancer (except localized skin or in situ cervical cancer) within 5 years
- Treatment or hospitalization for psychiatric disorders within past 12 months
- Major surgery within 3 months prior or planned during study
- History of alcohol or substance abuse within 12 months
- Participation in another study with active products or dietary interventions within 28 days prior to screening
- Living with another participant currently enrolled in this study
- Any other medical condition or medication use that may affect participation or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Apex Trials
Guelph, Ontario - on, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Adam Kuttenkeuler
CONTACT
S
Stephanie Recker
CONTACT
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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