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

McMaster University

Status: Withdrawn

Conditions: Aging

Treatments: Behavioral: Exercise plus diet (egg); Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04264013

7919

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Exercise

Placebo Comparator group

Description:

Exercise

Treatment:

Behavioral: Exercise

Exercise + Diet

Active Comparator group

Description:

Exercise + eggs

Treatment:

Behavioral: Exercise plus diet (egg)