The Impact of Consumption of Eggs in the Context of Plant-Based Diets on
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Endothelial Function (EF) Assessment:
研究概览
简要总结
Purpose To assess the impact of inclusion of 2 eggs daily for 6 weeks in an otherwise vegan diet compared to a vegan diet on cardio-metabolic risk and dietary pattern in adults at risk for type 2 diabetes.
Hypotheses In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve or have neutral effects on endothelial function and other markers of cardio-metabolic risk in adults at risk for type 2 diabetes.
(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.
(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.
详细描述
Specific Aims of the Proposed Project:
- To assess the impact of inclusion of 2 eggs daily for 6 weeks in an otherwise vegan diet, compared to a vegan diet, on endothelial function in adults at risk for T2DM. Specifically, to demonstrate superior or neutral effects on endothelial function with the inclusion of eggs in the context of otherwise vegan diets.
- To assess the impact of the inclusion of eggs daily for 6 weeks in an otherwise vegan diet, compared to a vegan diet, on dietary pattern and cardio-metabolic risk factors in adults at risk for T2DM. Specifically, to determine the effects on egg intake in the context of an otherwise vegan diet on diet quality and nutrient intake, lipid profile, blood pressure, insulin sensitivity and anthropometric measures.
Design:
Proposed is a randomized, single-blind, controlled, crossover trial designed with 2 treatment assignments (vegan diet plus eggs and vegan diet ) to compare the effects of 6 weeks of each treatment assignment on endothelial function, nutrient intake, diet quality, and cardio-metabolic risk factors in individuals at risk for T2DM. After a 4-week run-period of an ad libitum vegan diet, participants will be randomized to 1 of 2 possible sequence permutations and then undergo repeated measures following inclusion of 2 eggs per day in their otherwise vegan diet, or a vegan diet for 6 weeks, with a 4-week washout period between treatment assignments. The participants will continue their vegan diets during the 4-week washout period.
Background In the United States (U.S.), diabetes is a public health problem of epidemic proportions, affecting more than 30 million individuals. Only 23.1 million of these individuals are diagnosed. An estimated 84.1 million adults aged 18 years and older have prediabetes. Nearly 1 out 10 individuals with prediabetes is aware that he or she has this condition. Fifteen to thirty percent of individuals with prediabetes are likely to develop Type 2 diabetes mellitus (T2DM) within 5 years. The total medical costs, including lost work and wages, for individuals diagnosed with diabetes are estimated to be $245 billion. When compared with individuals without diabetes, individuals with diabetes have a medical cost that is more than two times higher. When compared with those without diabetes, the risk of death in individuals with diabetes is more than 50% higher. Between 90% and 95% of all diagnosed cases of diabetes are T2DM. The complications of diabetes include stroke, hypertension, cardiovascular disease (CVD), blindness, kidney disease, nervous system damage, limb amputations, and biochemical imbalances that can cause acute life-threatening events. [1] When compared with those without diabetes, the rates of cardiovascular mortality are 2 to 4 times higher among adults with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, 25-75 years or postmenopausal female 2) Non-smoker; 3) At risk for T2DM as defined by meeting at least one of the criteria listed:
- •Metabolic syndrome, i.e. meet three out of five of the following criteria:
- •blood pressure >130/85 mmHg or currently taking antihypertensive medication;
- •fasting plasma glucose (FPG) >100 mg/dL (6.1 mmol/L);
- •serum triglycerides level (TG)>150 mg/dL (1.69 mmol/L);
- •high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1.04 mmol/L) in men, and < 50 mg/dL (1.29 mmol/L) in women;
- •overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.
- •Fasting blood glucose >100mg/dL and <126mg/dL or hemoglobin A1C 5.7-6.4 %.
排除标准
- •Allergy to eggs; 2) Anticipated inability to complete the study protocol for any reason; 3) Current eating disorder; 4) Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning; 5) Regular use of high doses of vitamin E (>400IU/day) or vitamin C (>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and/or fiber supplement, unless willing to discontinue supplementation for the study duration; 6) Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators); 7) Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment; 8) Diagnosed diabetes; 9) Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months 10) Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis); 11) Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation; 12) Substance abuse (chronic alcoholism, other chemical dependency); 13) Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder); 14) For women: Use of hormone replacement therapy
研究组 & 干预措施
Egg phase:
Participants will meet with a registered dietitian and receive instructions to include 2 eggs per day for 6 weeks as part of their otherwise vegan diets.
干预措施: Egg included vegan phase (Other)
Control phase:
The participants will consume a vegan diet for 6 weeks.
干预措施: Vegan Phase (Other)
结局指标
主要结局
Change in Endothelial Function (EF) Assessment:
时间窗: 20 weeks
EF will be assessed at each of the 4 study visits and will be measured noninvasively in the right brachial artery by a high-frequency, 10-15 MHz, vascular ultrasound transducer (Philips iU22, Philips Medical Systems, Bothell, WA) in accordance with published guidelines. Endothelial function will be measured as Flow-mediated dilatation (FMD), that is the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release. In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity. To account for potential variability in stimulus strength, a secondary analysis will be performed in which FMD is divided by flow at 15 seconds post-cuff deflation to create a stimulus-adjusted response measure. All brachial artery reactivity studies (BARS) will be completed prior to noon.
次要结局
- Change in Body weight(20 weeks)
- Insulin Sensitivity(20 weeks)
- Change in Serum Lipids(20 weeks)
- Change in Body composition(20 weeks)
- Waist circumference(20 weeks)
- Office Blood Pressure(20 weeks)
- Change in Diet quality: Automated Self-Administered 24-Hour Recall (ASA24)(20 weeks)
- Change in Physical Activity(20 weeks)
研究者
VALENTINE NJIKE
PRINCIPAL INVESTIGATOR
Griffin Hospital