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Beef vs. broccoli: can a Meat-Heavy diet beat the USDA's best?

NCT ID NCT07269847

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study is testing whether a healthy diet centered around beef can reduce inflammation and improve metabolic health better than a standard U.S.-style diet based on USDA guidelines. Researchers will enroll 56 adults with metabolic syndrome or pre-diabetes and assign them to one of two 5-week meal plans. The goal is to see which diet better lowers markers of inflammation and other risk factors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dietary intervention (beef-centric diet vs. USDA-style diet)
What this could lead to
If it works, this could show that a well-planned beef-focused diet is as good as or better than standard dietary guidelines for managing inflammation and metabolic health.
What could go wrong
This is a small, short-term (5-week) diet study with only 56 participants, so results may not apply broadly. Dietary studies are hard to control, and personal adherence can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Apex Trials

    RECRUITING

    Guelph, Ontario - on, N1G 0B4, Canada

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