CompletedNCT02777918Updated Jul 29, 2019Results posted

Changing Habits and Lifestyles in Older Individuals

An interventional study of Recipe provision in Eating Behaviour, sponsored by Bournemouth University. Completed. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.

Sponsored by Bournemouth University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 55 Years and older
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Eating Behaviour

Keywords

food intake

In context

Lead sponsor

Bournemouth University is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
Intervention
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
No intervention
Control
Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations

Interventions

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

What researchers measure

Primary outcomes

Egg Intake
Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)
Time frame: Change from baseline to 12 weeks
Adverse Events
Self-declared adverse events over the intervention period, assessed by questionnaire
Time frame: Change from baseline to 12 weeks

Secondary outcomes

Change in Dietary Protein Intake
Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ
Time frame: Change from baseline to 12 weeks
Muscle Function
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.
Time frame: Change from baseline to 12 weeks
Lean Body Mass
Lean body mass over the intervention and follow-up period, assessed using bioimpedance
Time frame: Change from baseline to 12 weeks
Egg Intake
Egg intake over the follow-up period, assessed using an adapted FFQ.
Time frame: 6 months
Number of Adverse Events Reported
Self-declared adverse events over the follow-up period, assessed by questionnaire
Time frame: 6 months

Results

Posted Jul 29, 2019

Limitations and caveats

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

Participant flow

Participant flow — Overall Study
Milestone	Intervention	Control
Started	53	47
Completed	50	43
Not completed	3	4
Withdrew: Medical reasons	1	2
Withdrew: Too busy / stressed	1	1
Withdrew: Withdrawal by subject	1	1

Outcome measures

PrimaryEgg Intake

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

Time frame:: Change from baseline to 12 weeks
Reported as:: Mean · eggs

Egg Intake
eggs	Intervention	Control
Egg Intake	5 ± 20	4 ± 20

PrimaryAdverse Events

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

Time frame:: Change from baseline to 12 weeks
Reported as:: Mean · Adverse events

Adverse Events
Adverse events	Intervention	Control
Adverse Events	0.1 ± 1.9	0.3 ± 1.3

SecondaryChange in Dietary Protein Intake

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

Time frame:: Change from baseline to 12 weeks
Reported as:: Mean · g/day

Change in Dietary Protein Intake
g/day	Intervention	Control
Change in Dietary Protein Intake	-3 ± 29	3 ± 35

SecondaryMuscle Function

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.

Time frame:: Change from baseline to 12 weeks
Reported as:: Mean · scores on a scale

Muscle Function
scores on a scale	Intervention	Control
Muscle Function	0.6 ± 2.6	-0.2 ± 2.1

SecondaryLean Body Mass

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

Time frame:: Change from baseline to 12 weeks
Reported as:: Mean · g

Lean Body Mass
g	Intervention	Control
Lean Body Mass	-0.1 ± 12.6	-0.3 ± 12.8

SecondaryEgg Intake

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

Time frame:: 6 months
Reported as:: Mean · eggs

Egg Intake
eggs	Intervention	Control
Egg Intake	4 ± 22	1 ± 15

SecondaryNumber of Adverse Events Reported

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

Time frame:: 6 months
Reported as:: Mean · Number of adverse events reported

Number of Adverse Events Reported
Number of adverse events reported	Intervention	Control
Number of Adverse Events Reported	0.3 ± 1.5	0.5 ± 1.7

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intervention	0/53 (0%)	0/53 (0%)	53/53 (100%)
Control	0/47 (0%)	0/47 (0%)	47/47 (100%)

Most frequent other events

Most frequent other events
Event	Intervention	Control
Questionnaire self-reportGeneral disorders	53/53	47/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Intervention	Control	Total
Mean	70 ± 8	70 ± 7	70 ± 7

Sex: Female, Male
Sex: Female, Male(Participants)	Intervention	Control	Total
Female	30	24	54
Male	23	23	46

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Intervention	Control	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Intervention	Control	Total
United Kingdom	53	47	100

Study locations

No study locations are listed for this record.

References and documents

Study documents

Protocol and statistical analysis plan · Jul 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Group data will be made available on publication of the study

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02777918
Lead sponsor: Bournemouth University
Collaborators: British Egg Industry Council
Responsible party: Sponsor
First posted: May 19, 2016
Start date: Jun 1, 2016
Primary completion: Apr 30, 2017
Completion: Nov 29, 2017
Results posted: Jul 29, 2019
Last update: Jul 29, 2019

Study contacts

Katherine M Appleton, PhD

principal investigator · Bournemouth University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Bournemouth University

Start the discussion