Effects of Lean Pork, High Protein Breakfast on Satiety and Metabolic Health in Pre-diabetes

Completed · Not applicable

Conditions studied: Pre-diabetes

In brief

The goal of this study is to assess the effects of consumption of a lean pork-containing, high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and cardiometabolic parameters in overweight or obese adults with pre-diabetes.

Key facts

Study ID

NCT02934425

Run by

Midwest Center for Metabolic and Cardiovascular Research

People needed

22

Starts

2016-08-01

Expected to finish

2017-02-01

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index 25.0-39.9 kg/m2
• At least 1 of the following: a) capillary glycated hemoglobin 5.7-6.4%, b) fasting capillary glucose 100-125 mg/dL, or c) capillary glycated hemoglobin <5.7% and borderline fasting capillary glucose level 95-99 mg/dL and a subsequent fasting venous plasma glucose 100-125 mg/dL
• Self-identified "regular breakfast consumer" and willing to eat study foods as a breakfast meal
• Access to freezer and a food re-heating appliance
• Judged to be in good health on basis of medical history

You may not qualify if…

• Fasting laboratory test results of clinical significance (e.g., triglycerides ≥500 mg/dL, capillary glucose ≥126 mg/dL, glycated hemoglobin ≥6.5%)
• Uncontrolled hypertension
• Recent major trauma or surgical event
• Recent weight change ≥4.5 kg
• History or presence of clinically important endocrine, cardiovascular, pulmonary, biliary, or gastrointestinal disorders
• Recent history or presence of cancer (except non-melanoma skin cancer)
• History of extreme dietary habits
• Vegan or vegetarian
• History of eating disorder diagnosed by health professional
• Known intolerance or sensitivity to study products
• Unstable use of medications intended to alter lipid profile (e.g., unstable use of statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin-drug form, or omega-3-acid ethyl ester drugs)
• Recent use of foods or dietary supplements that might alter lipid metabolism (e.g., omega-3 fatty acid supplements or fortified foods, sterol/stanol products, pantethine, viscous dietary fiber supplements, red yeast supplements, garlic supplements, soy isoflavone supplements, probiotic supplements, niacin or analogues at >200 mg/d)
• Recent use of medications known to influence carbohydrate metabolism (e.g., adrenergic blockers, diuretics, hypoglycemic medications, systemic corticosteroids)
• Recent use of weight-loss drugs (including over-the-counter) or programs
• Recent history or current use of supplements and/or medications known to influence, satiety, appetite, taste, sense of smell, or weight (e.g., hypoglycemic medications and systemic corticosteroids)
• Recent use of antibiotics
• Signs or symptoms of active infection of clinical relevance
• Current or recent history of drug or alcohol abuse
• Pregnant, planning to be pregnant, or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception

Where it is running

• Illinois Institute of Technology - Institute for Food Safety and Health — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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