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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Exercise plus diet (egg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomized parallel-group trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle, Diet, Sarcopenia, Vascular health