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Completed

NCT Number: NCT02777918

Changing Habits and Lifestyles in Older Individuals

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.

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Key information

Conditions

Eating Behaviour Behavior Behavior, Animal Feeding Behavior

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals can be considered for inclusion if they meet the following inclusion criteria:

  • 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

Treatment and study plan

Recipe provision

Behavioral

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

Primary outcomes

  1. Egg Intake

    Time frame: Change from baseline to 12 weeks

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

  2. Adverse Events

    Time frame: Change from baseline to 12 weeks

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

Secondary outcomes

  1. Change in Dietary Protein Intake

    Time frame: Change from baseline to 12 weeks

    Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ

  2. Muscle Function

    Time frame: Change from baseline to 12 weeks

    Muscle function over the intervention and follow-up period, assessed using the Short Physical Performance Battery (Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85-M94). Higher scores denote better ability - range - 5.0 to +5.0.

  3. Lean Body Mass

    Time frame: Change from baseline to 12 weeks

    Lean body mass over the intervention and follow-up period, assessed using bioimpedance

  4. Egg Intake

    Time frame: 6 months

    Egg intake over the follow-up period, assessed using an adapted FFQ.

  5. Number of Adverse Events Reported

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Collaborators

  • British Egg Industry Council

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
Jul 29, 2019

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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