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

Not Applicable

Withdrawn

• Conditions: Aging
• Interventions: Behavioral: Exercise; Behavioral: Exercise plus diet (egg)

• Registration Number: NCT04264013
• Lead Sponsor: McMaster University

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 Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Start: 2020-05-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-05-01
• Status Verified: 2022-04
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Exercise
Exercise + Diet	Exercise plus diet (egg)	Exercise + eggs

Primary Outcome Measures

Name	Time	Method
Dietary protein intake.	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 Outcome Measures

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

Trial Locations

Locations (1)

Ivor Wynne Centre; 🇨🇦 Hamilton, Ontario, Canada