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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSeven Oaks Hospital Chronic Disease Innovation Centre

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Allergy to eggs

Inability to consume treatment product

Unable to provide written consent

Unable to understand English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Egg White Pudding

    Dietary supplement

    Participants will be given a high protein egg white pudding 5 days a week for 8 weeks.

  • Nestle Resource

    Dietary supplement

    Participants in the control group will be given 180 ml of Resource 2.0 seven days a week for 8 weeks.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hand Grip Strength

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

Secondary outcomes

1

Waist circumference

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
2

Body weight

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
3

Calf Circumference

The study staff will wrap a flexible tape measure around the widest part of participants' lower leg while keeping the tape snug but comfortable.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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