Sarcopenia in Elderly
Conditions
Keywords
Protein, Feasibility, Older Adults, Home Care Centres, Sarcopenia, Canada, Manitoba, Protein Pudding, Egg White Pudding, Mini Nutritional Assessment
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEgg White Pudding
Participants will be given a high protein egg white pudding 5 days a week for 8 weeks.
DIETARY_SUPPLEMENTNestle Resource
Participants in the control group will be given 180 ml of Resource 2.0 seven days a week for 8 weeks.
Sponsors
Seven Oaks Hospital Chronic Disease Innovation Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Residing in a partnering Personal Care Home * Participant is willing and able to give informed consent for participation in the trial or has an ADM who is authorized to provide consent on their behalf. * Male or female aged ≥50 years
Exclusion criteria
* Allergy to eggs * Inability to consume treatment product * Unable to provide written consent * Unable to understand English * Does not have an ADM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 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. |
| Body weight | 8 weeks | Body weight will be measured by participants stepping onto a digital or mechanical weighing scale placed on a hard, flat surface |
| Calf Circumference | 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. |
Countries
Canada
Contacts
CONTACTNavdeep Tangri, MD, PhD
CONTACTMaryem Zahra, BA
Outcome results
None listed