Eating Behaviour
Conditions
Keywords
food intake
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.
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.
Interventions
BEHAVIORALRecipe provision
6 recipes will be provided every 2 weeks by post for 12 weeks
Sponsors
British Egg Industry Council
Bournemouth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Egg Intake | Change from baseline to 12 weeks | Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ) |
| Adverse Events | Change from baseline to 12 weeks | Self-declared adverse events over the intervention period, assessed by questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Body Mass | Change from baseline to 12 weeks | Lean body mass over the intervention and follow-up period, assessed using bioimpedance |
| Change in Dietary Protein Intake | Change from baseline to 12 weeks | Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ |
| Number of Adverse Events Reported | 6 months | Self-declared adverse events over the follow-up period, assessed by questionnaire |
| Egg Intake | 6 months | Egg intake over the follow-up period, assessed using an adapted FFQ. |
| Muscle Function | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks | 53 |
| Control Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations | 47 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Medical reasons | 1 | 2 |
| Overall Study | Too busy / stressed | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 47 participants | 100 participants | 53 participants |
| Sex: Female, Male Female | 24 Participants | 54 Participants | 30 Participants |
| Sex: Female, Male Male | 23 Participants | 46 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 47 |
| other Total, other adverse events | 53 / 53 | 47 / 47 |
| serious Total, serious adverse events | 0 / 53 | 0 / 47 |
Outcome results
Primary
Adverse Events
Self-declared adverse events over the intervention period, assessed by questionnaire
Time frame: Change from baseline to 12 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Adverse Events | 0.1 Adverse events | Standard Deviation 1.9 |
| Control | Adverse Events | 0.3 Adverse events | Standard Deviation 1.3 |
Primary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Egg Intake | 5 eggs | Standard Deviation 20 |
| Control | Egg Intake | 4 eggs | Standard Deviation 20 |
Secondary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Dietary Protein Intake | -3 g/day | Standard Deviation 29 |
| Control | Change in Dietary Protein Intake | 3 g/day | Standard Deviation 35 |
Secondary
Egg Intake
Egg intake over the follow-up period, assessed using an adapted FFQ.
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Egg Intake | 4 eggs | Standard Deviation 22 |
| Control | Egg Intake | 1 eggs | Standard Deviation 15 |
Secondary
Lean Body Mass
Lean body mass over the intervention and follow-up period, assessed using bioimpedance
Time frame: Change from baseline to 12 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Lean Body Mass | -0.1 g | Standard Deviation 12.6 |
| Control | Lean Body Mass | -0.3 g | Standard Deviation 12.8 |
Secondary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Muscle Function | 0.6 scores on a scale | Standard Deviation 2.6 |
| Control | Muscle Function | -0.2 scores on a scale | Standard Deviation 2.1 |
Secondary
Number of Adverse Events Reported
Self-declared adverse events over the follow-up period, assessed by questionnaire
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Number of Adverse Events Reported | 0.3 Number of adverse events reported | Standard Deviation 1.5 |
| Control | Number of Adverse Events Reported | 0.5 Number of adverse events reported | Standard Deviation 1.7 |