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临床试验/NCT04264013
NCT04264013撤回不适用

Eggs as Nutrient-Rich Source of Protein to Enhance Activity-Related Health in Older Persons: The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Trial

McMaster University1 个研究点 分布在 1 个国家开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Dietary protein intake.

研究概览

简要总结

Two of the most effective lifestyle-based approaches to reduce the risk of adverse health events and enhance quality of life with aging are exercise and a healthy diet. Currently, the Canadian recommended dietary allowance (RDA) for protein is 0.8 g/kg/day, however, several expert groups have advocated for a higher RDA of protein (~1.2 g/kg/day), along with more evenly distributed daily consumption, in older persons. Eggs are considered a nutrient-rich protein source but have recently been scrutinized. This study will compare a high-protein, egg-containing diet and a high-protein, non-egg diet in healthy older persons.

详细描述

This study will examine the impacts of an egg-containing diet and a non-egg diet in healthy older persons. Briefly, participants (healthy persons, age 60-75 years old) will consume their normal diet or their normal diet plus 4 eggs completing a structured exercise program (designed to meet Canada's Physical Activity Guidelines) for a total of 12 weeks. Participants will be randomly assigned to the Egg or Control (non-egg) group. Before and after the 12-week intervention, participants' undergo assessments of diet-quality, muscle health, fitness, bone health, and vascular health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Exclusion Criteria:
  • •Use assistive walking devices (e.g. cane or walker)
  • •Consume any analgesic (pain-relieving) or anti-inflammatory drug(s), prescription or non-prescription, chronically
  • •A history of neuromuscular problems or muscle-wasting diseases
  • •Any acute chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders- all ascertained through medical screening questionnaires
  • •Chronic consumption of statins (particularly simvastatin/Zocor and atorvastatin/Lipitor) used to lower cholesterol
  • •Be on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
  • •Have allergies or are not willing to consume eggs
  • •Consume a vegetarian diet
  • •Had significant weight gain or loss in the past 6 months
  • •Have injuries preventing the safe completion of the exercise

排除标准

  • •Use assistive walking devices (e.g. cane or walker)
  • •Consume any analgesic (pain-relieving) or anti-inflammatory drug(s), prescription or non-prescription, chronically
  • •A history of neuromuscular problems or muscle-wasting diseases
  • •Any acute chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders- all ascertained through medical screening questionnaires
  • •Chronic consumption of statins (particularly simvastatin/Zocor and atorvastatin/Lipitor) used to lower cholesterol
  • •Be on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
  • •Have allergies or are not willing to consume eggs
  • •Consume a vegetarian diet
  • •Had significant weight gain or loss in the past 6 months
  • •Have injuries preventing the safe completion of the exercise

研究组 & 干预措施

Exercise

Placebo Comparator

Exercise

干预措施: Exercise (Behavioral)

Exercise + Diet

Active Comparator

Exercise + eggs

干预措施: Exercise plus diet (egg) (Behavioral)

结局指标

主要结局

Dietary protein intake.

时间窗: Pre- and post-intervention over 12 weeks

Dietary protein intake (specifically meal-to-meal distribution) will be measured in all participants using a 3-day food log.

次要结局

  • Change in lean mass(Pre- and post-intervention over 12 weeks)
  • Strength(Pre- and post-intervention over 12 weeks)
  • Vascular health(Pre- and post-intervention over 12 weeks)
  • Change in body fat mass(Pre- and post-intervention over 12 weeks)

研究者

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

Stuart Phillips

Professor

McMaster University

研究点 (1)

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