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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264013
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Stuart Phillips, McMaster University

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.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Exercise Behavioral: Exercise plus diet (egg) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a randomized parallel-group trial
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Exercise
Exercise
Behavioral: Exercise
Participants will exercise in a supervised facility twice weekly and consume their habitual diet.

Active Comparator: Exercise + Diet
Exercise + eggs
Behavioral: Exercise plus diet (egg)
Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.




Primary Outcome Measures :
  1. Dietary protein intake. [ Time Frame: Pre- and post-intervention over 12 weeks ]
    Dietary protein intake (specifically meal-to-meal distribution) will be measured in all participants using a 3-day food log.


Secondary Outcome Measures :
  1. Change in lean mass [ Time Frame: Pre- and post-intervention over 12 weeks ]
    Composition by DXA

  2. Strength [ Time Frame: Pre- and post-intervention over 12 weeks ]
    Handgrip strength

  3. Vascular health [ Time Frame: Pre- and post-intervention over 12 weeks ]
    Measures of arterial compliance

  4. Change in body fat mass [ Time Frame: Pre- and post-intervention over 12 weeks ]
    Composition by DXA



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264013


Contacts
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Contact: Brad Currier, BSc (636) 443-1585 currierb@mcmaster.ca
Contact: Jonathan McLeod, M.Sc. mcleoj2@mcmaster.ca

Locations
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Canada, Ontario
Ivor Wynne Centre
Hamilton, Ontario, Canada, L8S 4L8
Contact: Todd Prior, M.Sc.    (905) 525-9140 ext 23596    priort@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Stuart Phillips, Ph.D. McMaster University
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Responsible Party: Stuart Phillips, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT04264013    
Other Study ID Numbers: 7919
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stuart Phillips, McMaster University:
Muscle
Diet
Sarcopenia
Vascular health