Metabolic Syndrome study: Healthy Beef-Centric Diet
Official title Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Diet on Metabolic Health Outcomes in Pre-Diabetic Adults
ClinicalTrials.gov ID: NCT07269847
What this study is testing
- What it's testing
- The study wants to see how a healthy beef‑centric eating plan compares to a standard healthy U.S. diet for inflammation and other metabolic health measures.
- Who it's for
- Adults who have pre‑diabetes or metabolic syndrome are being recruited.
- What's involved
- Participants will be randomly assigned to follow either the beef‑centric diet or the U.S.‑style diet and will have regular check‑ups and lab tests to measure inflammation and metabolic health.
- Time commitment
- The trial lasts several months, with periodic clinic visits for diet counseling and blood tests.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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.
- Pre-diabetes (defined as an HbA1c of 5.7-6.4% [inclusive]), and/or
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can 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.
- Pre-diabetes (defined as an HbA1c of 5.7-6.4% [inclusive]), and/or
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Guelph, Ontario - on, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guelph, Ontario - on, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.