Clinical trial NCT04264013: The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Trial in Older Persons
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aging
Keywords: Muscle
Diet
Sarcopenia
Vascular health
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized parallel-group trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Dietary protein intake.
timeFrame: Pre- and post-intervention over 12 weeks
Secondary outcomes:
measure: Change in lean mass
timeFrame: Pre- and post-intervention over 12 weeks
measure: Strength
timeFrame: Pre- and post-intervention over 12 weeks
measure: Vascular health
timeFrame: Pre- and post-intervention over 12 weeks
measure: Change in body fat mass
timeFrame: Pre- and post-intervention over 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Ivor Wynne Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart Phillips, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: