The Saul and Claribel Simkin Centre
Winnipeg, Manitoba, Canada
Location status: Recruiting
NCT Number: NCT07805993
This trial is an open-label randomized controlled parallel arm feasibility trial. 54 residents in care homes receiving nutrition supplementation (minimum 40% of each sex, ≥ 50 years of age). Participants will receive the egg white pudding (experimental) or a standard currently provided dietary supplement (control) on a daily basis and will be advised to follow any dietary recommendations they receive from their care team. Participants will be recruited at personal care homes throughout Winnipeg. Study visits will take place with a study coordinator at baseline and at 8 weeks (endpoint). Product acceptability will be assessed through dietary logs. This study has been reviewed and approved by The Committee for Harmonized Health Impact, Privacy, and Ethics Review (CHIPER).
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, Canada
Location status: Recruiting
This trial is an open-label randomized controlled parallel arm feasibility trial. 54 residents from non-shared health personal care home centres (target of a minimum 40% of each sex, ≥ 50 years of age) will be recruited. Participants will receive the egg white pudding (experimental) 5 days a week or a standard currently provided dietary supplement (control) 7 days a week and will be advised to follow any dietary recommendations they receive from their care team. The personal care home team will approach residents or their ADM to participate in the research. Once a potential participant confirms interest, the research team will approach them for scheduling a screening visit. As part of the screening process, the care team may provide the research team with information on the participant's MDS (Minimum Data Set) level, which is routinely collected by personal care homes in Canada (levels 1-3). This information will be recorded at the screening visit for descriptive purposes only and will not be used to exclude any participants. The research coordinator and research assistant will also oversee and document the dispensing of products, which will be administered by the care team at the home care centre. After the screening visit, study visits will take place with a research coordinator or research assistant at Week 1 (baseline) and at Week 8 (endpoint). Product acceptability will be assessed through feedback questionnaire.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be given a high protein egg white pudding 5 days a week for 8 weeks.
Participants in the control group will be given 180 ml of Resource 2.0 seven days a week for 8 weeks.
Time frame: 8 weeks
Hand grip strength will be measured using a specialized handheld device called a hand dynamometer that records the maximum isometric force generated in kilograms or pounds.
Time frame: 8 weeks
The study staff will wrap a flexible tape measure around participants' middle at the level of the belly button or just above the hip bones.
Time frame: 8 weeks
Body weight will be measured by participants stepping onto a digital or mechanical weighing scale placed on a hard, flat surface
Time frame: 8 weeks
The study staff will wrap a flexible tape measure around the widest part of participants' lower leg while keeping the tape snug but comfortable.
Contact information is provided by the study sponsor or research team.
Maryem Zahra, BA
CONTACT
Navdeep Tangri, MD, PhD
CONTACT
Seven Oaks Hospital Chronic Disease Innovation Centre
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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