AgingEVEN-PNCT04264013
The Eggs and actiVity in hEalth agiNg Pilot (EVEN-P) Trial in Older Persons
A study testing Exercise and Exercise plus diet (egg) in people with Aging, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise and Exercise plus diet (egg)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Exercise, Exercise plus diet (egg)
- Keywords
- Muscle, Diet, Sarcopenia, Vascular health
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will exercise in a supervised facility twice weekly and consume their habitual diet.
Exercise plus diet (egg)Behavioural
Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Placebo comparator | Exercise Receives: Behavioral: Exercise |
| Exercise + Diet | Active comparator | Exercise + eggs Receives: Behavioral: Exercise plus diet (egg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary protein intake.
Dietary protein intake (specifically meal-to-meal distribution) will be measured in all participants using a 3-day food log.
Measured: Pre- and post-intervention over 12 weeks
Secondary outcomes (4)
Change in lean mass
Composition by DXA
Measured: Pre- and post-intervention over 12 weeks
Strength
Handgrip strength
Measured: Pre- and post-intervention over 12 weeks
Vascular health
Measures of arterial compliance
Measured: Pre- and post-intervention over 12 weeks
Change in body fat mass
Composition by DXA
Measured: Pre- and post-intervention over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 May 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized parallel-group trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264013
- Sponsor's protocol ID
- 7919
- Acronym
- EVEN-P
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04264013
- Acronym / sponsor ID
- EVEN-P / 7919
- Conditions
- Aging
- Keywords
- Muscle, Diet, Sarcopenia, Vascular health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a randomized parallel-group trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Placebo comparator | Behavioral: ExerciseExercise |
| Exercise + Diet | Active comparator | Behavioral: Exercise plus diet (egg)Exercise + eggs |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will exercise in a supervised facility twice weekly and consume their habitual diet. | Behavioural | Exercise |
| Exercise plus diet (egg)Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day. | Behavioural | Exercise + Diet |
Primary outcome
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.
4 secondary outcomes
Change in lean mass
Time frame: Pre- and post-intervention over 12 weeks
Strength
Time frame: Pre- and post-intervention over 12 weeks
Vascular health
Time frame: Pre- and post-intervention over 12 weeks
Change in body fat mass
Time frame: Pre- and post-intervention over 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Phillips, Ph.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Exercise plus diet (egg) in people with Aging, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary protein intake. (time frame: Pre- and post-intervention over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.