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Metabolic Syndrome (MetS)NCT07269847

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

A study testing Healthy Beef-Centric Diet and Healthy U.S.-Style Dietary Pattern in people with Metabolic Syndrome (MetS) and Inflammation, run by National Cattlemen's Beef Association, a contractor to the Beef Checkoff at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
Healthy Beef-Centric Diet and Healthy U.S.-Style Dietary Pattern
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteCanada
Study dates
10 Feb 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Apex Trials

    Guelph, Ontario - on, N1G 0B4

    Katie Keene, 226-706-2545, kkeene@apextrials.com

    Anthony Bier, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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 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.

Read the detailed description

This study follows a randomized, open-label, parallel design to compare the effects 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.

The comparator diet in this study is a U.S. Department of Agriculture (USDA) Healthy U.S.-Style Dietary Pattern, as outlined in the 2020 Dietary Guidelines for Americans, which emphasizes the consumption of nutrient-dense foods across all food groups in recommended amounts. This includes a variety of vegetables, fruits, whole grains, low-fat dairy, lean protein sources, and healthy oils, while limiting added sugars, saturated fats, and sodium.

The test diet in this study involves a healthy beef-centric diet, where beef is the main source of protein. Participants will consume 70% of their daily energy intake from beef. The rest of their calories will come from other protein and fat sources (20%), along with a small amount (10%) from low-carbohydrate fruits (such as berries) and vegetables (like dark leafy greens). This diet excludes all grains. While the carbohydrate intake is low, it is slightly higher than that of a typical ketogenic diet.

The healthy beef-centric diet is being investigated for its effects on metabolic health after a 5 week intervention period. This study will investigate whether a beef-centric diet will support management of glycemic control, inflammation, and lipid-related risk factors, while also enhancing quality of life.

Being tested
Healthy Beef-Centric Diet, Healthy U.S.-Style Dietary Pattern
Keywords
Healthy Beef-Centric Diet, Healthy U.S.-Style Dietary Pattern, Inflammation, Metabolic Syndrome, Pre-Diabetes
Medical subject headings
Metabolic Syndrome, Inflammation, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Beef-Centric DietOther

    Also called Test Diet (TD)

    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 PatternOther

    Also called Comparator Diet (CD)

    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.

Study groups in NCT07269847
Study groupRoleWhat they receive
Healthy U.S.-Style Dietary PatternActive comparatorThis 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.
Receives: Other: Healthy U.S.-Style Dietary Pattern
Healthy Beef-Centric DietExperimentalThis 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.
Receives: Other: Healthy Beef-Centric Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline to Week 5

Secondary outcomes (16)
  1. 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

    Measured: Baseline to Week 5

  2. 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

    Measured: Baseline to Week 5

  3. 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

    Measured: Baseline to Week 5

  4. 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

    Measured: Baseline to Week 5

  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

    Change from baseline to Week 5 in the fasting insulin serum

    Measured: Baseline to Week 5

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

    Change from baseline to Week 5 in the fasting glucose serum

    Measured: Baseline to Week 5

  7. To evaluate the effect of a healthy beef-centric diet on glycemic patterns in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in mean 72-hour interstitial glucose levels, as assessed by continuous glucose monitoring (CGM) over 3-day periods

    Measured: Baseline to Week 5

  8. To evaluate the effect of a healthy beef-centric diet on quality of life in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in quality of life, as assessed by the Food Benefits Assessment (FBA) Questionnaire on a 5-point Likert Scale: items are scored from 1 (Never / Certainly not) to 5 (Always / Certainly). The scores are transformed on a scale from 0 to 100 with higher scores indicating higher positive impact and/or satisfaction from daily diet.

    Measured: Baseline to Week 5

  9. To evaluate the effect of a healthy beef-centric diet on blood lipids (total cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the total cholesterol parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  10. To evaluate the effect of a healthy beef-centric diet on blood lipids (high-density lipoprotein (HDL) cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the HDL cholesterol parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  11. To evaluate the effect of a healthy beef-centric diet on blood lipids (low-density lipoprotein (LDL) cholesterol) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the LDL cholesterol parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  12. To evaluate the effect of a healthy beef-centric diet on blood lipids (HDL:LDL ratio) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the HDL:LDL ratio parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  13. To evaluate the effect of a healthy beef-centric diet on blood lipids (triglycerides) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the triglycerides parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  14. To evaluate the effect of a healthy beef-centric diet on blood lipids (apolipoprotein B (ApoB)) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the ApoB parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  15. To evaluate the effect of a healthy beef-centric diet on blood lipids (lipid fraction) in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in the lipid fraction parameter of an advanced lipid profile

    Measured: Baseline to Week 5

  16. To evaluate the effect of a healthy beef-centric diet on short-term average glucose control in a MetS and/or pre-diabetic population, compared to a healthy U.S.-style dietary pattern

    Change from baseline to Week 5 in average blood glucose, as assessed by fructosamine levels

    Measured: Baseline to Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start10 Feb 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269847
Sponsor's protocol ID
B06-25-01-T0086
Status last verified
Aug 2026
First submitted
14 Nov 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Beef-Centric Diet and Healthy U.S.-Style Dietary Pattern in people with Metabolic Syndrome (MetS) and Inflammation, run by National Cattlemen's Beef Association, a contractor to the Beef Checkoff at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adam Kuttenkeuler (519-341-3367, akuttenkeuler@nutrasource.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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