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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Metabolic Effects of Replacing Dietary Refined Carbohydrate With a Combination of Egg Protein and Unsaturated Fats in Men and Women With Elevated Triglycerides

Brief Summary: The goal of this study is to evaluate the effects of replacing some refined starches and added sugars with a combination of egg protein and unsaturated fatty acids on markers of cardiometabolic health in men and women with hypertriglyceridemia.

Detailed Summary: 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.
Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Current Primary Outcome: Matsuda composite index of insulin sensitivity (MISI) [ Time Frame: 3 weeks ]

Difference between treatments in percent change from baseline to end of treatment MISI calculated from glucose and insulin responses to the LMTT at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Lipoprotein lipids [ Time Frame: 3 weeks ]
    Difference between treatments in percent change from baseline to end of treatment fasting triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), and TC/HDL-C ratio based on the average of values collected at Visits 1 and 2, Days -7 and 0 (baseline); Visits 5 and 6, Days 19 and 21 (end of treatment period I); and Visits 10 and 11, Days 19 and 21 (end of treatment period II)
  • Lipoprotein particle concentrations [ Time Frame: 3 weeks ]
    Difference between treatments in change from baseline to end of treatment lipoprotein particle subclass concentrations and sizes, as well as cholesterol carried by major lipoproteins and subfractions analyzed using an ion mobility assay at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment of period II)
  • Apolipoprotein (Apo) B [ Time Frame: 3 weeks ]
    Difference between treatments in percent change from baseline to end of treatment apo B at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)
  • Homeostasis model assessment of insulin sensitivity (HOMA2-%S) [ Time Frame: 3 weeks ]
    Difference between treatments in change from baseline to end of treatment HOMA2-%S calculated from fasting values of insulin and glucose at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)
  • LMTT disposition index [ Time Frame: 3 weeks ]
    Difference between treatments in the percent change from baseline to end of treatment LMTT disposition index calculated from insulin and glucose responses during the LMTT at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)
  • Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B) [ Time Frame: 3 weeks ]
    Difference between treatments in change from baseline to end of treatment HOMA2%B calculated from fasting insulin and glucose values at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)
  • Blood pressure [ Time Frame: 3 weeks ]
    Difference between treatments in change from baseline to end of treatment in systolic and diastolic blood pressures based on the average of values collected at Visits 1and 2, Days -7 and 0 (baseline); Visits 5 and 6, Days 19 and 21 (end of treatment period I); and Visits 10 and 11, Days 19 and 21 (end of treatment period II)


Original Secondary Outcome: Same as current

Information By: Midwest Center for Metabolic and Cardiovascular Research

Dates:
Date Received: October 3, 2016
Date Started: February 2015
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016