The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Trial in Older Persons (EVEN-P)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Aging
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Exercise plus diet (egg)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • Ivor Wynne Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Exclusion Criteria:

1. Use assistive walking devices (e.g. cane or walker)
2. Consume any analgesic (pain-relieving) or anti-inflammatory drug(s), prescription or non-prescription, chronically
3. A history of neuromuscular problems or muscle-wasting diseases
4. 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
5. Chronic consumption of statins (particularly simvastatin/Zocor and atorvastatin/Lipitor) used to lower cholesterol
6. Be on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
7. Have allergies or are not willing to consume eggs
8. Consume a vegetarian diet
9. Had significant weight gain or loss in the past 6 months
10. Have injuries preventing the safe completion of the exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Exercise	Behavioral: Exercise; Participants will exercise in a supervised facility twice weekly and consume their habitual diet.
Active Comparator: Exercise + Diet; Exercise + eggs	Behavioral: Exercise plus diet (egg); Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary protein intake.	Dietary protein intake (specifically meal-to-meal distribution) will be measured in all participants using a 3-day food log.	Pre- and post-intervention over 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lean mass	Composition by DXA	Pre- and post-intervention over 12 weeks
Strength	Handgrip strength	Pre- and post-intervention over 12 weeks
Vascular health	Measures of arterial compliance	Pre- and post-intervention over 12 weeks
Change in body fat mass	Composition by DXA	Pre- and post-intervention over 12 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Stuart Phillips, Ph.D., McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Diet; Sarcopenia; Muscle; Vascular health
• Other Study ID Numbers: 7919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No