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PreDiabetesNCT05456477

A Trial to Assess Diets Containing Beef vs. Poultry on Pancreatic Beta-Cell Function

A study testing Beef and Poultry in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess and compare the effects of usual diets containing lean beef vs. lean poultry on pancreatic beta-cell responses in men and women with prediabetes. Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
PreDiabetes
What is being tested?
Beef and Poultry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
7 Oct 2022to 22 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female 18 to 74 y of age, inclusive.
  • Subject has a BMI of 25.0-39.9 kg/m2, inclusive.
  • Subject has a Vein Access Scale score of 7-10.
  • Subject has prediabetes as indicated by a fasting plasma glucose of 100-125 mg/dL and/or HbA1c of 5.7%-6.4% at screening.
  • Subject is normally active and judged by the Investigator to be in general good health on the basis of medical history and screening measurements.
  • Subject is willing to consume study-related foods and follow the dietary instructions during each 4-week treatment period.
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  • Subject is willing to come to the clinic for study food pick-up if needed.
  • Subject is willing to follow his/her usual physical activity pattern throughout the study period.
  • Subject agrees to avoid meat, poultry, seafood, and eggs, other than the study entrées, for the duration of the treatment periods.
  • Subject has no plans to change smoking habits during the study period.
  • Subject is willing to refrain from consumption of recreational marijuana and alcoholic beverages for 24 h prior to each clinic visit.
  • Subject is willing to refrain from vigorous physical activity for 24 h prior to each clinic visit.
  • Subject is willing to abstain from tobacco/nicotine products and caffeine use for at least 1 h prior to and during each clinic visit.
  • Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.

Who cannot join

  • Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
  • Subject has fasting blood glucose ≥ 126 mg/dL and/or HbA1c ≥ 6.5% at screening and/or known type 1 or type 2 diabetes mellitus.
  • Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic [e.g., myocardial infarction, angina, transient ischemic attack, or stroke of carotid origin] or > 50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
  • Subject has history or presence of a clinically significant health condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
  • Subject has a history of cancer in the prior 2 years, other than non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Subject has uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) at screening.
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  • Subject has unstable use (defined as initiation or change in dose) of anti-hypertensive medication or thyroid hormone replacement within 4 weeks of screening (Appendix 1).
  • Subject has used alpha- or beta-adrenergic blockers and/or high-dose (> 25 mg/d) thiazide diuretics within 4 weeks of screening (Appendix 1).
  • Subject has used diabetes medications including any alpha-glucosidase inhibitor, biguanide (metformin), thiazolidinedione, dipeptidyl peptidase-4 inhibitor, meglitinide, sulfonylurea, Sodium-glucose Cotransporter-2 inhibitor, or GLP-1 receptor agonist within 4 weeks of screening (Appendix 1).
  • Subject has used systemic corticosteroids within 4 weeks of screening (Appendix 1).
  • Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 4 weeks prior to screening (Appendix 1).
  • Subject has used dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a supplement) and starch blockers within 2 weeks of screening (Appendix 1).
  • Subject has used any lipid altering drug therapy except stable use statin therapy (stable use is defined as no change in agent, dose, or regimen in the 4 weeks prior to screening).
  • Subject has had a weight change of ± 4.5 kg (10 lbs) in the previous 3 months.
  • Subject has an active infection and/or is on antibiotic therapy. Subject can be rescheduled for screening at least 7 days after completion of antibiotic therapy.
  • Subject has restrictive dietary habits (e.g., vegan, vegetarian, or very low carbohydrate diet).
  • Subject has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
  • Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Subject has a known allergy, sensitivity, or intolerance to any of the study foods.
  • Subject has been exposed to any non-registered drug product within 30 days of screening.
  • Subject has a current or recent history (past 12 months of screening) or strong potential for illicit drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
  • Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Illinois Institute of Technology

    Chicago, Illinois, 60616

Other trials in United States

About this study

Official title: A Randomized, Crossover Trial to Assess the Effects of Diets Containing Lean Beef vs. White Meat on Pancreatic Beta-cell Function in Men and Women With Prediabetes

The objective of this study is to assess and compare the effects of usual diets containing lean beef vs. lean poultry on pancreatic beta-cell responses in men and women with prediabetes.

Conditions
PreDiabetes
Being tested
Beef, Poultry
Medical subject headings
Prediabetic State

What participants receive

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

  • BeefOther

    Beef entrees

  • PoultryOther

    Poultry entrees

Study groups in NCT05456477
Study groupRoleWhat they receive
BeefExperimentalSubject will consume beef entrees each day of the study period, and will not consume any additional meat, poultry, seafood, and eggs, other than the study entrees.
Receives: Other: Beef
PoultryActive comparatorSubject will consume poultry entrees each day of the study period, and will not consume any additional meat, poultry, seafood, and eggs, other than the study entrees.
Receives: Other: Poultry

What is being measured

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

  1. Ratio of incremental area under the curve (iAUC) for C-peptide to iAUC for glucose

    Measured: 4 weeks

Secondary outcomes (13)

  1. Insulin sensitivity

    The percent change during each treatment period in the Matsuda index where insulin resistance is defined as a value on the matsuda index of less than 3.

    Measured: 4 weeks

  2. Fasting C-peptide

    Change or percent change from baseline to the end of treatment of fasting C-peptide.

    Measured: 4 weeks

  3. Insulin

    Change or percent change from baseline to the end of treatment of insulin.

    Measured: 4 weeks

  4. Mixed meal tolerance test (MTT) Disposition index

    Change or percent change from baseline to the end of treatment of mixed meal tolerance test (MTT) disposition index.

    Measured: 4 weeks

  5. Homeostasis model assessments of pancreatic beta-cell function (HOMA2%B)

    Change or percent change from baseline to the end of treatment of homeostasis model assessment of pancreatic beta-cell function (HOMA2%B).

    Measured: 4 weeks

  6. Homeostasis model assessments of insulin sensitivity (HOMA2%S)

    Change or percent change from baseline to the end of treatment of homeostasis model assessment of insulin sensitivity (HOMA2%S).

    Measured: 4 weeks

  7. Glucagon

    Total AUC and iAUC for glucagon.

    Measured: 4 weeks

  8. Glucagon-like petide-1 (GLP-1)

    Total AUC and iAUC for glucagon-like peptide-1.

    Measured: 4 weeks

  9. Glucose-dependent inhibitory polypeptide (GIP)

    Total AUC and iAUC for glucose-dependent inhibitory polypeptide.

    Measured: 4 weeks

  10. High-sensitivity C-reactive protein

    Changes or percent changes from baseline to the end of treatment

    Measured: 4 weeks

  11. Fibrinogen

    Changes or percent changes from baseline to the end of treatment

    Measured: 4 weeks

  12. Tumor necrosis factor alpha

    Changes or percent changes from baseline to the end of treatment

    Measured: 4 weeks

  13. Interleukin-6

    Changes or percent changes from baseline to the end of treatment

    Measured: 4 weeks

Timeline

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

  1. First posted13 Jul 2022
  2. Study start7 Oct 2022
  3. Primary completion22 Sep 2023
  4. Study completion22 Sep 2023

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05456477
Sponsor's protocol ID
MB-2112
Status last verified
Oct 2023
First submitted
7 Jul 2022
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guzman E, Edirisinghe I, Wilcox ML, Kirkpatrick CF, Adams CG, Burton-Freeman BM, Maki KC. Effects of Diets Containing Beef Compared with Poultry on Pancreatic beta-Cell Function and Other Cardiometabolic Health Indicators in Males and Females with Prediabetes: A Randomized, Crossover Trial. Curr Dev Nutr. 2025 Oct 30;9(12):107589. doi: 10.1016/j.cdnut.2025.107589. eCollection 2025 Dec.

    PubMed 41377490

Questions about this trial

What is this clinical trial studying?

A study testing Beef and Poultry in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.

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 14 inclusion and 22 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: finished, as of the sponsor's last update on 18 Oct 2023. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of incremental area under the curve (iAUC) for C-peptide to iAUC for glucose (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05456477, which also lists 1 linked publication.

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 18 Oct 2023.

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