Recruiting

Beef-Centric Diet & U.S.-Style Diet

Sponsor:

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

Code:

NCT07269847

Conditions

Metabolic Syndrome (MetS)

Inflammation

Pre-Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Healthy Beef-Centric Diet

Healthy U.S.-Style Dietary Pattern

Study Details

Brief summary:

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

Metabolic Syndrome (MetS)

Inflammation

Pre-Diabetes

Study ID

NCT07269847

Start date

Feb 10, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Have the following conditions at screening:

1. Pre-diabetes (defined as an HbA1c of 5.7-6.4% \[inclusive\]), and/or
2. MetS, i.e., have 3 of the 5 following metabolic criteria:

  • A waist circumference of more than 40 inches (102 cm) in men and 35 inches (88 cm) in women
  • Serum triglycerides level of 150 mg/dL (1.7 mmol/L) or greater
  • Reduced HDL cholesterol, less than 40 mg/dL (1.0 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women
  • Elevated fasting glucose of 100 mg/dL (5.6 mmol/L) or greater
  • Blood pressure values of systolic 130 mmHg or higher or diastolic 85 mmHg or higher
  • Report low to moderate levels of physical activity, as defined by a "low" or "moderate" activity classification on the IPAQ-SF (if ≤69 YOA) or IPAQ-E (if ≥70 YOA) at screening.
  • Consume meat-based protein as a part of their normal diet and regularly consume beef.
  • Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine containing products (patches, gums, vapes, etc.), and willing to abstain for 14 days before Visit 2 until the last procedure.
  • Have maintained a stable, self-reported body weight for at least 6 months prior to screening (maximum ±10% change in self-reported body weight).
  • Willing and able to consume all aspects of either study dietary intervention.
  • Willing to adhere to all study dietary intervention prohibitions and restrictions.
  • Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions).
  • Agree to follow the restrictions on concomitant treatments.
  • Agree to follow the restrictions on lifestyle.
  • Agree to avoid pregnancy throughout the study if of childbearing potential by using any preferred contraceptive method.
  • Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion Criteria:

  • 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.
  • Have blood pressure of ≥ 160 systolic or ≥ 100 diastolic mmHg.
  • Have a history or current diagnosis of eating disorders such as anorexia or bulimia.
  • Have current symptoms, or symptoms within the past 7 days, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator.
  • Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of protein, fat, or micronutrients (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
  • Have a history of gallbladder disease (e.g., cholelithiasis, cholecystitis), cholecystectomy, gout, or kidney stones.
  • Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
  • Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years before the screening visit.
  • Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
  • Major surgery in 3 months prior to screening or planned major surgery during the study.
  • Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be a concern for the study.
  • Current enrollment or past participation in another study with either any product(s) with at least one active ingredient or a dietary intervention, within 28 days before screening or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
  • Living in the same household as another currently enrolled participant in the present study.
  • Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Healthy U.S.-Style Dietary Pattern

This diet is based on USDA's MyPlate dietary guidelines and includes a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. This diet reflects a conventional, guideline-based approach to healthy eating.

experimental: Healthy Beef-Centric Diet

This 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.

Interventions

Healthy Beef-Centric Diet

The 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

The 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.

Primary outcome measure

  • 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 [ Time Frame: Baseline to Week 5 ]

Central Contacts and Locations

Locations

Apex Trials

Recruiting

Guelph, Ontario - on, Canada, N1G 0B4

Contacts

Principal Investigator:

Anthony Bier, MD

More Information

Sponsor

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

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Healthy Beef-Centric Diet
  • Healthy U.S.-Style Dietary Pattern
  • Inflammation
  • Metabolic Syndrome
  • Pre-Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cattlemen's Beef Association, a contractor to the Beef Checkoff on 2026-08-31.