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

NCT04264013 | Withdrawn

• 1 other identifier: 7919
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Muscle; Diet; Sarcopenia; Vascular health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Exercise

PLACEBO COMPARATOR

Exercise

Behavioral: Exercise

Exercise + Diet

ACTIVE COMPARATOR

Exercise + eggs

Behavioral: Exercise plus diet (egg)

Interventions

Exercise BEHAVIORAL

Participants will exercise in a supervised facility twice weekly and consume their habitual diet.

Exercise

Exercise plus diet (egg) BEHAVIORAL

Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.

Exercise + Diet

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Ivor Wynne Centre

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise; Diet; Eggs

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food; Food and Beverages

Study Officials

• Stuart Phillips, Ph.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will be a randomized parallel-group trial

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 11, 2020
• Study Start: May 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 14, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)