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

NCT07269847 | Recruiting

• 1 other identifier: B06-25-01-T0086
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to Week 5

Secondary Outcomes (16)

• 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

  Baseline to Week 5

• 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

  Baseline to Week 5

• 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

  Baseline to Week 5

• 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

  Baseline to Week 5

• To evaluate the effect of a healthy beef-centric diet on glucose control (fasting insulin serum) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

  Baseline to Week 5

Other Outcomes (29)

• To evaluate the effect of a healthy beef-centric diet and a healthy U.S.-style dietary pattern on total caloric intake

  Baseline to Week 5

• To assess the safety (vital signs) of the healthy beef-centric diet

  Baseline to Week 5

• To assess the safety of the healthy beef-centric diet (Hemoglobin)

  Baseline to Week 5

Study Arms (2)

Healthy U.S.-Style Dietary Pattern

ACTIVE COMPARATOR

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.

Other: Healthy U.S.-Style Dietary Pattern

Healthy Beef-Centric Diet

EXPERIMENTAL

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.

Other: Healthy Beef-Centric Diet

Interventions

Healthy Beef-Centric Diet OTHER

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.

Also known as: Test Diet (TD)

Healthy Beef-Centric Diet

Healthy U.S.-Style Dietary Pattern OTHER

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.

Also known as: Comparator Diet (CD)

Healthy U.S.-Style Dietary Pattern

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Pre-diabetes (defined as an HbA1c of 5.7-6.4% \[inclusive\]), and/or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: lead

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation; Glucose Intolerance

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperglycemia

Study Officials

• Shalene McNeill

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

  STUDY CHAIR

Central Study Contacts

Adam Kuttenkeuler

CONTACT

519-341-3367; akuttenkeuler@nutrasource.ca

Stephanie Recker

CONTACT

519-341-3367; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)