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

NCT05456477 | Completed

• 1 other identifier: MB-2112
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (13)

• Insulin sensitivity

  4 weeks

• Fasting C-peptide

  4 weeks

• Insulin

  4 weeks

• Mixed meal tolerance test (MTT) Disposition index

  4 weeks

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

  4 weeks

Study Arms (2)

Beef

EXPERIMENTAL

Subject 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.

Other: Beef

Poultry

ACTIVE COMPARATOR

Subject 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.

Other: Poultry

Interventions

Beef OTHER

Beef entrees

Beef

Poultry OTHER

Poultry entrees

Poultry

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• 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.

  PMID: 41377490 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Red Meat; Poultry

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevin Maki, PhD

  MB Clinical Research & Consulting, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: October 7, 2022
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)