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| Name | Class |
|---|---|
| British Egg Industry Council | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recipe provision | Behavioral | 6 recipes will be provided every 2 weeks by post for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Protein Intake | Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ | 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. |
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Inclusion Criteria:
Individuals can be considered for inclusion if they meet the following inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine M Appleton, PhD | Bournemouth University | Principal Investigator |
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Group data will be made available on publication of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Egg Intake | Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ) | ITT | Posted | Mean | Standard Deviation | eggs | Change from baseline to 12 weeks |
|
6 months
self-report questionnaire assessing number of unusual experiences of nausea, digestive issues (e.g. constipation or diarrhoea), stomach aches/cramps, hunger, bloating/uncomfortable fullness, thirst, headaches, fatigue/tiredness, restlessness, dizziness, or skin rashes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Questionnaire self-report | General disorders | Systematic Assessment | Any unspecified general physical disorder |
Anticipated, but small sample. Should be treated as a pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Katherine Appleton | Bournemouth University | +441202965985 | k.appleton@bournemouth.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2018 | Feb 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| Change from baseline to 12 weeks |
| Lean Body Mass | Lean body mass over the intervention and follow-up period, assessed using bioimpedance | Change from baseline to 12 weeks |
| Egg Intake | Egg intake over the follow-up period, assessed using an adapted FFQ. | 6 months |
| Number of Adverse Events Reported | Self-declared adverse events over the follow-up period, assessed by questionnaire | 6 months |
| Withdrawal by Subject |
|
| Control |
Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Adverse Events | Self-declared adverse events over the intervention period, assessed by questionnaire | ITT | Posted | Mean | Standard Deviation | Adverse events | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Dietary Protein Intake | Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ | ITT | Posted | Mean | Standard Deviation | g/day | Change from baseline to 12 weeks |
|
|
|
| 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. | ITT | Posted | Mean | Standard Deviation | scores on a scale | Change from baseline to 12 weeks |
|
|
|
| Secondary | Lean Body Mass | Lean body mass over the intervention and follow-up period, assessed using bioimpedance | ITT | Posted | Mean | Standard Deviation | g | Change from baseline to 12 weeks |
|
|
|
| Secondary | Egg Intake | Egg intake over the follow-up period, assessed using an adapted FFQ. | ITT | Posted | Mean | Standard Deviation | eggs | 6 months |
|
|
|
| Secondary | Number of Adverse Events Reported | Self-declared adverse events over the follow-up period, assessed by questionnaire | ITT | Posted | Mean | Standard Deviation | Number of adverse events reported | 6 months |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 53 |
| 53 |
| EG001 | Control | Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations | 0 | 47 | 0 | 47 | 47 | 47 |
|
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