Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Diet on Metabolic Health Outcomes in Pre-Diabetic Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorNational Cattlemen's Beef Association, a contractor to the Beef Checkoff

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

56 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Lead sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator