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.
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.
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.
Parallel
Healthy Beef-Centric Diet
Other interventionThe TD is a whole-food dietary pattern that emphasizes beef as the primary source of protein. This diet is designed to reflect a low-carbohydrate, minimally processed eating pattern.
Healthy U.S.-Style Dietary Pattern
Other interventionThe CD is based on the USDA's MyPlate dietary guidelines and includes a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. The CD reflects a conventional, guideline-based approach to healthy eating.
To evaluate the effect of a healthy beef-centric diet on inflammation in a metabolic syndrome (MetS) and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in inflammatory marker composite (combination of hs-CRP, IL-6, IL-10, IL-1β, and TNF-α)
To evaluate the effect of a healthy beef-centric diet on systolic blood pressure (SBP) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in SBP
To evaluate the effect of a healthy beef-centric diet on diastolic blood pressure (DBP) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in DBP
To evaluate the effect of a healthy beef-centric diet on body weight in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in body weight
To evaluate the effect of a healthy beef-centric diet on body mass index (BMI) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern
Change from baseline to Week 5 in BMI
To evaluate the effect of a healthy beef-centric diet and a healthy U.S.-style dietary pattern on total caloric intake
Change from baseline to Week 5 in total caloric intake
To assess the safety (vital signs) of the healthy beef-centric diet
Vital signs (heart rate \[HR\])
To assess the safety of the healthy beef-centric diet (Hemoglobin)
Safety Laboratory Parameters - Hematology Parameters (Hemoglobin)
To assess the safety of the healthy beef-centric diet (Hematocrit)
Safety Laboratory Parameters - Hematology Parameters (Hematocrit)
Click on the lead sponsor to view all of their trials.
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
