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Feasibility of Egg White Pudding Supplementation for Individuals in Personal Care Home Centres Needing Dietary Supplementation

S

Seven Oaks Hospital Chronic Disease Innovation Centre

Status

Enrolling

Conditions

Sarcopenia in Elderly

Treatments

Dietary Supplement: Nestle Resource
Dietary Supplement: Egg White Pudding

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT07805993
HS26476

Details and patient eligibility

About

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).

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Control
Active Comparator group
Description:
Resource 2.0
Treatment:
Dietary Supplement: Nestle Resource
Experimental
Experimental group
Description:
Egg White Pudding
Treatment:
Dietary Supplement: Egg White Pudding

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Maryem Zahra, BA; Navdeep Tangri, MD, PhD

Data sourced from clinicaltrials.gov

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