Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes

NCT03202680 | Completed

• 1 other identifier: MB-1606
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to compare the effects of a healthy, lean beef diet and an average American, United States Department of Agriculture (USDA) style diet, that is low in saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for diabetes mellitus.

Conditions

Metabolic Syndrome; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity index (Si)

  Differences in the change from baseline between test conditions (lean beef diet and USDA diet) in the insulin sensitivity index (Si) using the short IVGTT.

  Up to 50 minutes - measured at baseline, and end of each treatment period.

Secondary Outcomes (15)

• Disposition index of pancreatic beta-cell function [Si x acute insulin response to intravenous glucose (AIRg)]

  Up to 50 minutes - measured at baseline, and end of each treatment period.

• Fractional glucose disappearance constant from t = 10-50 min (Kg)

  Up to 50 minutes - measured at baseline, and end of each treatment period.

• Homeostasis model assessment of beta cell function (HOMA%B) and insulin sensitivity (HOMA%S)

  Up to 28 days for each treatment period.

• Insulin sensitivity (HOMA%S)

  Up to 28 days for each treatment period.

• Total Cholesterol (TC)

  Up to 28 days for each treatment period.

Study Arms (2)

USDA Style Diet

ACTIVE COMPARATOR

Healthy, low saturated fat, United States Department of Agriculture (USDA) style diet.

Other: USDA Style Diet

Lean Beef Diet

EXPERIMENTAL

Healthy, low saturated fat, high in lean beef diet.

Other: Lean Beef Diet

Interventions

USDA Style Diet OTHER

USDA style healthy diet, low in saturated fats.

USDA Style Diet

Lean Beef Diet OTHER

A lean beef containing healthy diet, low in saturated fats.

Lean Beef Diet

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of 25.0-39.9 kg/m2.
• Metabolic syndrome (exhibiting at least 3 out of 5 of the criteria) AND/OR prediabetes (either fingerstick glycated hemoglobin 5.7-6.4%, fasting fingerstick capillary glucose of 100-125 mg/dL, or 2-h post-prandial glucose of 140-199 mg/dL).
• Fasting LDL-C level \<200 mg/dL and fasting TG level \<400 mg/dL.
• Willingness to consume only study-related foods/beverages during each test period and consume all of the study foods provided for each day.
• Willingness to come to the clinic for study food pick-up as needed.

You may not qualify if:

• Atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease \[symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or \>50% stenosis on angiography or ultrasound\], history of myocardial infarction, angina, or other forms of clinical atherosclerotic disease (e.g., renal artery disease).
• History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or type 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders.
• Known allergy, sensitivity, or intolerance to any ingredients in the study foods (e.g., dairy, nuts, etc.).
• Uncontrolled hypertension.
• Recent history of cancer except for non-melanoma skin cancer.
• Recent change in body weight of ± 4.5 kg (10 lbs).
• Unstable use of any antihypertensive medication.
• Recent use of medications intended to alter the lipid profile \[e.g., bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors\], weight-loss drugs or programs, systemic corticosteroid drugs, medications known to influence carbohydrate metabolism (e.g., adrenergic receptor blockers, diuretics, and/or hypoglycemic medications).
• Recent use of foods or dietary supplements known to influence lipid metabolism (e.g., omega-3 fatty acids supplements or fortified foods, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues at doses \>400 mg/d and irregular or inconsistent use of Metamucil® or viscous fiber-containing supplements.
• Recent use of antibiotics.
• Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
• Extreme dietary habits (e.g., very low carbohydrate diet, vegan, vegetarian, etc.) or unwillingness to consume study foods.
• Current or recent history or strong potential for drug or alcohol abuse.
• History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
• Recent exposure to any non-registered drug product.

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)

MB Clinical Research, LLC

Boca Raton, Florida, 33487, United States

Location

Related Publications (1)

• Maki KC, Wilcox ML, Dicklin MR, Buggia M, Palacios OM, Maki CE, Kramer M. Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes. J Nutr. 2020 Jul 1;150(7):1824-1833. doi: 10.1093/jn/nxaa116.

  PMID: 32359153 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: July 6, 2017
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)