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Comparing Healthy U.S.-Style Dietary Pattern with Healthy Beef-Centric Diet for metabolic syndrome (mets)

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

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

Condition: Metabolic Syndrome (MetS)Sponsor: National Cattlemen's Beef Association, a contractor to the Beef CheckoffTarget enrollment: 56
  • 2 groups
  • One site, in Guelph
  • Recruiting
Apex Trials, Guelph, Ontario - on

Interventions

  • Other intervention

    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.

  • Other intervention

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Apex Trials

    Guelph, Ontario - on

    Recruiting

Eligibility Criteria

See who this study is looking for40 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Participant must be 18 - 74 years of age (inclusive) at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
  • +Have a BMI range of 23.0 - 39.9 kg/m2 (inclusive).
  • +Pre-diabetes (defined as an HbA1c of 5.7-6.4% \[inclusive\]), and/or
  • +In otherwise generally good health as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
  • +Have blood hs-CRP levels equal to or greater than 2.0 mg/L at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • +Have the following conditions at screening:
  • +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.
  • +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.
  • +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.
  • +Agree to avoid pregnancy throughout the study if of childbearing potential by using any preferred contraceptive method.
  • +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.

Exclusion

  • Have a known sensitivity, intolerability, or allergy to any of the components of the study dietary interventions and/or CGM sensor.
  • 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 followed and maintained a ketogenic, Mediterranean, low-carbohydrate, vegetarian, vegan or any other special diet in the 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
  • 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 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.).
  • 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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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.
  • Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test at Visit 2.
  • Major surgery in 3 months prior to screening or planned major surgery during the study.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study does not fall into the standard research categories.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives Healthy U.S.-Style Dietary Pattern.

Registry label: A: Healthy U.S.-Style Dietary Pattern

Group B receives Healthy Beef-Centric Diet.

Registry label: B: Healthy Beef-Centric Diet

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 74 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 56 people.

The study is currently expected to finish around February 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 5.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

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 — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 5.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07269847 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Healthy Beef-Centric DietOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Healthy U.S.-Style Dietary PatternOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 74 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 74 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 5.

The study as a whole is currently expected to finish around 2027-02.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 56 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Guelph, Ontario - on, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.