Clinical trial NCT02924558: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: Egg
Protein
Unsaturated fatty acids
Triglycerides
Insulin sensitivity
Lipid triad
Lead sponsor: Midwest Center for Metabolic and Cardiovascular Research
Sponsor class: OTHER
Collaborators: name: American Egg Board
name: Egg Nutrition Center
First posted: 2016-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Matsuda composite index of insulin sensitivity (MISI)
timeFrame: 3 weeks
Secondary outcomes:
measure: Lipoprotein lipids
timeFrame: 3 weeks
measure: Lipoprotein particle concentrations
timeFrame: 3 weeks
measure: Apolipoprotein (Apo) B
timeFrame: 3 weeks
measure: Homeostasis model assessment of insulin sensitivity (HOMA2-%S)
timeFrame: 3 weeks
measure: LMTT disposition index
timeFrame: 3 weeks
measure: Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B)
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Midwest Center for Metabolic and Cardiovascular Research
name: Kevin C Maki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.