Metabolic Effects of Egg Protein and Unsaturated Fat Intakes in Subjects With Hypertriglyceridemia

The objective of this study is to evaluate the effects of a combination of egg protein and unsaturated fatty acids acting as substitutes for ~16% of energy from refined carbohydrate on the metabolic profile of men and women with elevated triglycerides. This is a randomized, controlled feeding, crossover trial that includes two screening/baseline visits, two 3-week treatment conditions, and a 2-week washout phase. Subjects consume a standardized background diet (7-day rotating menu) that incorporates at least 3 servings/day of study test foods, providing 40-60% of subjects' daily energy needs. Study test foods consist of yogurt, muffins, waffles, and cookies. The test foods account for 8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids) in the Active Condition compared to the Control Condition. In the Control Condition, the study foods account for 16% higher carbohydrate energy. The overall macronutrient composition of each condition is as follows: Active Condition, approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively, and Control Condition, approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively. Blood samples will be collected at baseline and end of treatment for measurement of metabolic parameters, and a liquid meal tolerance test (LMTT) will be conducted at baseline and the end of each treatment period.

Inclusion criteria

• Fasting TG level 150-499 mg/dL
• Body mass index (BMI) 25.0-39.9 kg/m2
• Score of 7-10 on Vein Access Scale
• Normally active and judged to be in general good health on basis of medical history and routine laboratory tests

Exclusion criteria

• Fasting blood glucose ≥126 mg/dL or known type 1 or type 2 diabetes mellitus
• Atherosclerotic cardiovascular disease
• Recent history or current significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease
• Abnormal lab test results of clinical significance (e.g., creatinine ≥1.5 mg/dL and aspartate or alanine transaminase ≥1.5 times upper limit of normal)
• History of cancer in previous 2 years
• Uncontrolled hypertension
• Recent unstable use of anti-hypertensive medication, thyroid hormone replacements, and/or medications known to substantially influence carbohydrate metabolism
• Recent use of certain blood pressure medications (e.g., beta-adrenergic blockers and/or high-dose thiazide diuretics)
• Recent use of lipid-altering drugs (e.g., statins, bile acid sequestrants, cholesterol absorption inhibitors, or fibrates)
• Recent use of diabetes medication (e.g., alpha-glucosidase inhibitors, biguanides and biguanide combinations, bile acid sequestrants, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides, and sulfonylureas and combination sulfonylureas)
• Recent use of lipid-altering foods, herbs, or dietary supplements (e.g., niacin, sterol/stanol products, dietary fiber supplements, red rice yeast supplements)
• Recent unstable use of herbs and dietary supplements that may influence carbohdyrate metabolism
• Extreme dietary habits, dietary restrictions, or significant food allergies
• Required energy intake <2200 kcal/day or >3400 kcal/day
• Recent change in body weight of ±4.5 kg
• Recent use of weight loss drugs or programs
• Active infection or on antibiotic therapy
• 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