Metabolic Effects of Replacing Dietary Refined Carbohydrate With a Combination of Egg Protein and Unsaturated Fats in Men and Women With Elevated Triglycerides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Matsuda composite index of insulin sensitivity (MISI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Egg protein/unsaturated fatty acid
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
干预措施: Egg protein/unsaturated fatty acid (Other)
Control
16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively
干预措施: Control (Other)
结局指标
主要结局
Matsuda composite index of insulin sensitivity (MISI)
时间窗: 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)
次要结局
- Homeostasis model assessment of insulin sensitivity (HOMA2-%S)(3 weeks)
- Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B)(3 weeks)
- Lipoprotein lipids(3 weeks)
- Lipoprotein particle concentrations(3 weeks)
- Apolipoprotein (Apo) B(3 weeks)
- LMTT disposition index(3 weeks)
- Blood pressure(3 weeks)