The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Tria... | NCT04264013

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

NCT04264013

Sponsor

McMaster University

Status

Withdrawn

Last Update Posted

Mar 14, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Aging

Interventions

Exercise
Exercise plus diet (egg)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Placebo Comparator	Exercise	Behavioral: Exercise
Exercise + Diet	Active Comparator	Exercise + eggs	Behavioral: Exercise plus diet (egg)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	Participants will exercise in a supervised facility twice weekly and consume their habitual diet.	Exercise

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Phillips, Ph.D.	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivor Wynne Centre		Hamilton	Ontario	L8S 4L8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D004032	Diet
D004531	Eggs

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided