--- title: Metabolic Effects of Egg Protein and Unsaturated Fat Intakes in Subjects With Hypertriglyceridemia nct_id: NCT02924558 overall_status: COMPLETED phase: NA sponsor: Midwest Center for Metabolic and Cardiovascular Research study_type: INTERVENTIONAL primary_condition: Hypertriglyceridemia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02924558.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02924558" ct_last_update_post_date: 2018-05-15 last_seen_at: "2026-05-12T07:31:21.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT02924558](https://clinicaltrials.gov/study/NCT02924558) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 28 - **Lead Sponsor:** Midwest Center for Metabolic and Cardiovascular Research - **Collaborators:** American Egg Board, Egg Nutrition Center - **Conditions:** Hypertriglyceridemia - **Start Date:** 2015-02 - **Completion Date:** 2016-02 - **CT.gov Last Update:** 2018-05-15 ## 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 - **Minimum age:** 21 Years - **Maximum age:** 70 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Egg protein/unsaturated fatty acid** (EXPERIMENTAL) — 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 - **Control** (PLACEBO_COMPARATOR) — 16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively ## Interventions - **Egg protein/unsaturated fatty acid** (OTHER) — 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 - **Control** (OTHER) — Study test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid ## Primary Outcomes - **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) ## Secondary Outcomes - **Lipoprotein lipids** _(time frame: 3 weeks)_ - **Lipoprotein particle concentrations** _(time frame: 3 weeks)_ - **Apolipoprotein (Apo) B** _(time frame: 3 weeks)_ - **Homeostasis model assessment of insulin sensitivity (HOMA2-%S)** _(time frame: 3 weeks)_ - **LMTT disposition index** _(time frame: 3 weeks)_ - **Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B)** _(time frame: 3 weeks)_ - **Blood pressure** _(time frame: 3 weeks)_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02924558.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02924558* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*