NCT02777918

Brief Summary

This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed
Last Updated

July 29, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

May 17, 2016

Results QC Date

May 3, 2018

Last Update Submit

June 3, 2019

Conditions

Keywords

food intake

Outcome Measures

Primary Outcomes (2)

  • Egg Intake

    Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)

    Change from baseline to 12 weeks

  • Adverse Events

    Self-declared adverse events over the intervention period, assessed by questionnaire

    Change from baseline to 12 weeks

Secondary Outcomes (5)

  • Change in Dietary Protein Intake

    Change from baseline to 12 weeks

  • Muscle Function

    Change from baseline to 12 weeks

  • Lean Body Mass

    Change from baseline to 12 weeks

  • Egg Intake

    6 months

  • Number of Adverse Events Reported

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes.

Behavioral: Recipe provision

Control

NO INTERVENTION

Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations

Interventions

6 recipes will be provided every 2 weeks by post for 12 weeks

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 55 years old
  • living in the community
  • being able to give consent
  • not being allergic to eggs
  • not suffering from known renal insufficiency, or having a pacemaker or defibrillator.
  • not suffering from known hypercholesterolaemia, or known familial hypercholesterolaemia.
  • not having undergone chemotherapy or radiotherapy in the last 6 months
  • not suffering from any condition, or receiving medication or treatment that the participants feel affects their eating or sense of flavour.
  • being able to perform the physical performance tests (e.g. walk, sit on a chair)
  • being able to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Limitations and Caveats

Anticipated, but small sample. Should be treated as a pilot study.

Results Point of Contact

Title
Prof. Katherine Appleton
Organization
Bournemouth University

Study Officials

  • Katherine M Appleton, PhD

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

June 1, 2016

Primary Completion

April 30, 2017

Study Completion

November 29, 2017

Last Updated

July 29, 2019

Results First Posted

July 29, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Group data will be made available on publication of the study