About this trial
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.
Eligibility criteria
Qualifiers
Participant must be 18 - 74 years of age (inclusive) at the time of signing the informed consent.
Have a BMI range of 23.0 - 39.9 kg/m2 (inclusive).
In otherwise generally good health as determined by the investigator.
Have blood hs-CRP levels equal to or greater than 2.0 mg/L at screening.
Disqualifiers
Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test at Visit 2.
Have a known sensitivity, intolerability, or allergy to any of the components of the study dietary interventions and/or CGM sensor.
Have followed and maintained a ketogenic, Mediterranean, low-carbohydrate, vegetarian, vegan or any other special diet in the 3 months prior to screening.
Have been diagnosed with Type I or II diabetes or thyroid disease.
Trial design
Treatments tested in this trial
- Healthy Beef-Centric Diet
- Healthy U.S.-Style Dietary Pattern
Treatment groups
Locations
1Sponsors and collaborators
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator