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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Egg protein/unsaturated fatty acid
Control
Sponsored by
Midwest Center for Metabolic and Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Egg, Protein, Unsaturated fatty acids, Triglycerides, Insulin sensitivity, Lipid triad

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Egg protein/unsaturated fatty acid

    Control

    Arm Description

    8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids); approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively

    16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively

    Outcomes

    Primary Outcome Measures

    Matsuda composite index of insulin sensitivity (MISI)
    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)

    Secondary Outcome Measures

    Lipoprotein lipids
    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
    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
    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)
    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
    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)
    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
    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)

    Full Information

    First Posted
    October 3, 2016
    Last Updated
    May 11, 2018
    Sponsor
    Midwest Center for Metabolic and Cardiovascular Research
    Collaborators
    American Egg Board, Egg Nutrition Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02924558
    Brief Title
    Metabolic Effects of Egg Protein and Unsaturated Fat Intakes in Subjects With Hypertriglyceridemia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Midwest Center for Metabolic and Cardiovascular Research
    Collaborators
    American Egg Board, Egg Nutrition Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia
    Keywords
    Egg, Protein, Unsaturated fatty acids, Triglycerides, Insulin sensitivity, Lipid triad

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Egg protein/unsaturated fatty acid
    Arm Type
    Experimental
    Arm Description
    8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids); approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively
    Intervention Type
    Other
    Intervention Name(s)
    Egg protein/unsaturated fatty acid
    Intervention Description
    Study test foods (yogurt, muffins, waffles, and cookies) containing 8% higher protein energy (egg protein) and 8% higher fat energy (unsaturated fatty acids) than Control
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Study test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid
    Primary Outcome Measure Information:
    Title
    Matsuda composite index of insulin sensitivity (MISI)
    Description
    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)
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Lipoprotein lipids
    Description
    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)
    Time Frame
    3 weeks
    Title
    Lipoprotein particle concentrations
    Description
    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)
    Time Frame
    3 weeks
    Title
    Apolipoprotein (Apo) B
    Description
    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)
    Time Frame
    3 weeks
    Title
    Homeostasis model assessment of insulin sensitivity (HOMA2-%S)
    Description
    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)
    Time Frame
    3 weeks
    Title
    LMTT disposition index
    Description
    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)
    Time Frame
    3 weeks
    Title
    Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B)
    Description
    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)
    Time Frame
    3 weeks
    Title
    Blood pressure
    Description
    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)
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin C Maki, PhD
    Organizational Affiliation
    Midwest Center for Metabolic and Cardiovascular Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28515160
    Citation
    Maki KC, Palacios OM, Lindner E, Nieman KM, Bell M, Sorce J. Replacement of Refined Starches and Added Sugars with Egg Protein and Unsaturated Fats Increases Insulin Sensitivity and Lowers Triglycerides in Overweight or Obese Adults with Elevated Triglycerides. J Nutr. 2017 Jul;147(7):1267-1274. doi: 10.3945/jn.117.248641. Epub 2017 May 17.
    Results Reference
    derived

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

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