Skip to main content
Clinical Trials/NCT04264013
NCT04264013WithdrawnNot Applicable

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 site in 1 countryStarted: May 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Dietary protein intake.

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
60 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

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

Arms & Interventions

Exercise

Placebo Comparator

Exercise

Intervention: Exercise (Behavioral)

Exercise + Diet

Active Comparator

Exercise + eggs

Intervention: Exercise plus diet (egg) (Behavioral)

Outcomes

Primary Outcomes

Dietary protein intake.

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stuart Phillips

Professor

McMaster University

Study Sites (1)

Loading locations...

Similar Trials