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临床试验/NCT04234334
NCT04234334已完成不适用

Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet

University of Connecticut1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Plasma lutein

研究概览

简要总结

The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.

详细描述

Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).

Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.

Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.

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
Single (Participant)

盲法说明

Egg or Egg substitutes (whites only) will be provided to subjects and since they are similar in appearance and color, they will not know when they are consuming them

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All genders
  • •35-70 years
  • •Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference. 88 cm for women and > 102 cm for men; plasma triglycerides > 150 mg/dL, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women)
  • •Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
  • •Willing to follow a plant-based diet for 13 weeks
  • •Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease
  • •Proficient in English

排除标准

  • •Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
  • •Taking glucose lowering medications
  • •Triglycerides > 500 mg/dL
  • •Cholesterol > 240 mg/dL
  • •Blood pressure > 145/100 mm Hg
  • •Allergic to eggs or spinach

研究组 & 干预措施

Egg intake

Experimental

Consumption of 2 eggs with spinach daily for breakfast for 4 weeks

干预措施: Consume 2 eggs with spinach per day (Other)

Egg Subsitute

Experimental

Consumption of 2 egg substitutes daily for breakfast for 4 weeks

干预措施: Egg Subsitute with spinach per day (Other)

结局指标

主要结局

Plasma lutein

时间窗: 1 year

Plasma lutien will be measured by HPLC. The units are expresses as µmol/L

Plasma choline

时间窗: 1 year

It will be measured by mass spectometry. The units are expressed as nmol/mL

Plasma Zeaxanthin

时间窗: 1 year

Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L

次要结局

  • Plasma lipids(1 year)
  • Plasma glucose(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Luz Fernandez

Professor

University of Connecticut

研究点 (1)

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