Changing Habits and Lifestyles in Older Individuals

Eating Behaviour Clinical Trial

Official title:

Changing Habits and Lifestyles in Older Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777918
• Other study ID #: BUREC12036
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: November 29, 2017

Study information

• Verified date: June 2019
• Source: Bournemouth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 29, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Behaviour

Intervention

Behavioral:
• Recipe provision
6 recipes will be provided every 2 weeks by post for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bournemouth University	British Egg Industry Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse Events	Self-declared adverse events over the intervention period, assessed by questionnaire	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	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.	Change from baseline to 12 weeks
Secondary	Lean Body Mass	Lean body mass over the intervention and follow-up period, assessed using bioimpedance	Change from baseline to 12 weeks
Secondary	Egg Intake	Egg intake over the follow-up period, assessed using an adapted FFQ.	6 months
Secondary	Number of Adverse Events Reported	Self-declared adverse events over the follow-up period, assessed by questionnaire	6 months