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

Aging Clinical Trial

— EVEN-P  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04264013
• Other study ID #: 7919
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Exercise
Participants will exercise in a supervised facility twice weekly and consume their habitual diet.
• Exercise plus diet (egg)
Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.

Locations

Country	Name	City	State
Canada	Ivor Wynne Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in lean mass	Composition by DXA	Pre- and post-intervention over 12 weeks
Secondary	Strength	Handgrip strength	Pre- and post-intervention over 12 weeks
Secondary	Vascular health	Measures of arterial compliance	Pre- and post-intervention over 12 weeks
Secondary	Change in body fat mass	Composition by DXA	Pre- and post-intervention over 12 weeks