RecruitingNCT07269847Updated Aug 31, 2026

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

An interventional study of Healthy Beef-Centric Diet and Healthy U.S.-Style Dietary Pattern in Metabolic Syndrome (MetS), Inflammation and Pre-Diabetes, sponsored by National Cattlemen's Beef Association, a contractor to the Beef Checkoff. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by National Cattlemen's Beef Association, a contractor to the Beef Checkoff · Not applicable, Interventional, and Other

From the registry’s dates

Started Feb 2026; still recruiting 9 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 18 Years to 74 Years
Sex: All

Study 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 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.

Conditions studied

Metabolic Syndrome (MetS)
Inflammation
Pre-Diabetes

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Keywords

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

In context

Metabolic Syndrome

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

This study's planned enrollment of 56 is close to the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

This is the only study on the registry with National Cattlemen's Beef Association, a contractor to the Beef Checkoff as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participant must be 18 - 74 years of age (inclusive) at the time of signing the .
Have a 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 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 by using any preferred 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

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 (i.e., /AIDS).
Have a history of cancer (except localized skin cancer without 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.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 56 participants (estimated)

Study arms

Active comparator
Healthy U.S.-Style Dietary Pattern
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
Experimental
Healthy Beef-Centric Diet
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

OtherHealthy 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.
Also known as: Test Diet (TD)
OtherHealthy 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.
Also known as: Comparator Diet (CD)

What researchers measure

Primary outcomes

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)
Time frame: Baseline to Week 5

Secondary outcomes

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
Time frame: 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
Change from baseline to Week 5 in DBP
Time frame: 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
Change from baseline to Week 5 in body weight
Time frame: 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
Change from baseline to Week 5 in BMI
Time frame: 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
Change from baseline to Week 5 in the fasting insulin serum
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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.
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5
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
Time frame: Baseline to Week 5

Other outcomes

To evaluate the effect of a healthy beef-centric diet and a healthy U.S.-style dietary pattern on total caloric intake
Change from baseline to Week 5 in total caloric intake
Time frame: Baseline to Week 5
To assess the safety (vital signs) of the healthy beef-centric diet
Vital signs (heart rate \[HR\])
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Hemoglobin)
Safety Laboratory Parameters - Hematology Parameters (Hemoglobin)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Hematocrit)
Safety Laboratory Parameters - Hematology Parameters (Hematocrit)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (White Blood Cell (WBC) count)
Safety Laboratory Parameters - Hematology Parameters (WBC count with differentials: neutrophils, eosinophils, basophils, lymphocytes, monocytes)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Red Blood Cell (RBC) count)
Safety Laboratory Parameters - Hematology Parameters (RBC Count)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Red Blood Cell Distribution Width (RCDW))
Safety Laboratory Parameters - Hematology Parameters (RCDW)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Mean Corpuscular Volume (MCV))
Safety Laboratory Parameters - Hematology Parameters, RBC Index - MCV
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Mean Corpuscular Hemoglobin (MCH))
Safety Laboratory Parameters - Hematology Parameters, RBC Index - MCH
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Mean Corpuscular Hemoglobin Concentration (MCHC))
Safety Laboratory Parameters - Hematology Parameters, RBC Index - MCHC
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Platelet count)
Safety Laboratory Parameters - Hematology Parameters (Platelet count)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Mean Platelet Volume (MPV))
Safety Laboratory Parameters - Hematology Parameters (MPV)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Blood smear)
Safety Laboratory Parameters - Hematology Parameters (Blood smear)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Sodium)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Sodium)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Potassium)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Potassium)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Chloride)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Chloride)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Blood urea nitrogen (BUN))
Safety Laboratory Parameters - Clinical Chemistry Parameters (BUN)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Creatinine)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Creatinine)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Estimated glomerular filtration rate (eGFR))
Safety Laboratory Parameters - Clinical Chemistry Parameters (eGFR)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Total protein)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Total protein)
Time frame: Baseline to Week 5
. To assess the safety of the healthy beef-centric diet (Albumin)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Albumin)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Globulin)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Globulin)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Total bilirubin)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Total bilirubin)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Fasted glucose)
Safety Laboratory Parameters - Clinical Chemistry Parameters (Fasted glucose)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Alanine transaminase (ALT))
Safety Laboratory Parameters - Clinical Chemistry Parameters (ALT)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Aspartate transaminase (AST))
Safety Laboratory Parameters - Clinical Chemistry Parameters (AST)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Alkaline phosphatase (ALP))
Safety Laboratory Parameters - Clinical Chemistry Parameters (ALP)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (Gamma glutamyl transferase (GGT))
Safety Laboratory Parameters - Clinical Chemistry Parameters (GGT)
Time frame: Baseline to Week 5
To assess the safety of the healthy beef-centric diet (adverse event reports)
Reports of adverse events (AEs)
Time frame: Baseline to Week 5

Study locations

1 of 1 sites recruiting

Apex Trials
Guelph, Ontario - on N1G 0B4, Canada
5 other open studies at this site →
Recruiting
- Katie Keene · Contact · kkeene@apextrials.com · 226-706-2545
- Anthony Bier, MD · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07269847
Lead sponsor: National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party: Sponsor
First posted: Dec 8, 2025
Start date: Feb 10, 2026
Primary completion: Feb 2027 (estimated)
Completion: Feb 2027 (estimated)
Last update: Aug 31, 2026

Study contacts

Adam Kuttenkeuler

Contact

akuttenkeuler@nutrasource.ca

519-341-3367

Stephanie Recker

Contact

srecker@nutrasource.ca

519-341-3367 ext. 109

Shalene McNeill

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

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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