Healthy beef-centric diet versus a Healthy U.S.-Style diet for adults with pre-diabetes or metabolic syndrome
A Randomized Study 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
This 5-week randomized test will see if a beef-centered, low-carbohydrate diet reduces inflammation and improves metabolic health in adults with pre-diabetes or metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | National Cattlemen's Beef Association, a contractor to the Beef Checkoff Industry-sponsored |
| Locations | 1 site (Guelph, Ontario - on) |
| Trial ID | NCT07269847 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label, parallel-group dietary intervention comparing a healthy beef-centric diet to the USDA Healthy U.S.-Style Dietary Pattern over 5 weeks. The beef-centric diet provides about 70% of daily energy from beef, excludes grains, and is low in carbohydrates but slightly higher than a ketogenic diet; the comparator follows nutrient-dense recommendations from the 2020 Dietary Guidelines for Americans. Primary outcomes include markers of inflammation (hs-CRP) and metabolic measures such as glycemic control and lipid-related risk factors. The study enrolls adults with elevated hs-CRP and either pre-diabetes or metabolic syndrome and is conducted at a site in Guelph, Ontario, sponsored by the National Cattlemen's Beef Association with contract research support.
Who should consider this trial
Good fit: Adults 18–74 years old with BMI 23.0–39.9 kg/m2, hs-CRP ≥2.0 mg/L, and either pre-diabetes (HbA1c 5.7–6.4%) or metabolic syndrome (three or more criteria) are ideal candidates.
Not a fit: People with normal glucose regulation or low systemic inflammation (hs-CRP <2.0 mg/L), BMI outside the eligible range, or those who cannot or will not follow a beef-centric, grain-free diet are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the beef-centric diet could offer an alternative eating pattern to lower inflammation, improve blood sugar control, and favorably modify lipid risk factors in people with pre-diabetes or metabolic syndrome.
How similar studies have performed: Short-term low-carbohydrate diets have improved glycemic control in prior studies, but a predominantly beef-centered, grain-free diet is relatively untested and its longer-term cardiovascular effects are uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guelph, Ontario - on
- Apex Trials — Guelph, Ontario - on, Canada (Recruiting)
Study contacts
- Study coordinator: Adam Kuttenkeuler
- Email: akuttenkeuler@nutrasource.ca
- Phone: 519-341-3367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.