Adults aged 50 years and above with a BMI of 25 kg/m2 or above Not Applicable
Conditions
Interventions
Minimisation randomisation using a validated randomised software module embedded in the PROTECT platform.
Participants will be randomised into three treatment groups:
1. DailyColors (TM) phytonutrien
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 50 years or above 2. BMI >25 kg/m2 3. Living within 2 hours travel from Exeter 4. Already a participant in the PROTECT-UK study 5. Access to a tablet or computer with an internet connection 6. Good understanding of the English Language, sufficient to participate
Exclusion criteria
Exclusion criteria: 1. Already taking part in another active interventional clinical trial 2. Vegan diet 3. Drinking more than five cups of coffee or tea per day 4. Regular consumption of anti-inflammatory medications 5. Use of dietary supplements rich in polyphenols (concentrate/freeze-dried powder of cherry, blueberry, pomegranate or cacao) 6. Current prescription of atorvastatin, simvastatin, calcium channel blocker (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine, verapamil), warfarin, clopidogrel, ticagrelor, ciclosporin, sirolimus, tacrolimus and entocort due to contraindications of high intake of grapefruit 7. Diagnosis of dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition as measured by the FLAME computerised cognitive test system, as described below: 1. Cognition will be assessed at baseline and 60 days on the PROTECT platform within the DailyColorsTM study bespoke study area. Cognition will be assessed using the FLAME cognitive test system which involves eight cognitive tests and takes up to 45 minutes to complete. They can be completed on either a computer with a keyboard and mouse or a touchscreen device. Participants will be encouraged to complete the tests at the same time of day on each test occasion. A video explaining the tests will be shown prior to the completion of the tests. The tests are presented in a set sequence according to the paradigm validated in the published FLAME cognitive composite measure which has proven sensitivity for detecting cognitive status and change over time. The tests are: 2. Picture Recognition Stage One: A series of 20 pictures of everyday scenes and objects is presented on the screen, at the rate of one picture every three seconds, for the participant to remember. The participant is instructed that the pictures will all be reshown later mixed with very similar ones. 3. Self-Ordered Search (SOS) task assessing spatial working memory: spatial working memory is measured through this widely used test. Participants search a series of on-screen boxes to find a hidden symbol. Once found, participants search for the symbol again, remembering that the symbol will never be hidden in the same box twice. The symbol is hidden in every box once per level. After successfully completing a level, a new level opens with more boxes to search than the previous level. The outcome measure is the average number of boxes in the successfully completed trials. Participants are allowed three errors before the test terminates. 4. Paired Associate Learning (PAL) task assessing visual episodic memory: verbal short-term memory is measured through the paired associates learning test, which is widely used in th | — |
Secondary
| Measure | Time frame |
|---|---|
| Full cohort: 1. Digital outcomes of health and wellbeing: the following validated measures will be completed by the participant on the study website at baseline, 30 and 60 days: 1.1. Self-reported cognition measured by the IQCODE that is clinically validated for the detection of cognitive status 1.2. Quality of life measured by the EQ5D measure with EQ-VAS 1.3. Instrumental Activities of Daily Living measured by a modified self-reported six-item IADL 1.4. Symptoms of mood and depression, measured by the nine-item Patient Health Questionnaire (PHQ-9) 1.5. Symptoms of anxiety, measured by the seven-item Generalised Anxiety Disorder (GAD-7) scale 1.6. Sleep quality measured by the short-form Cognition Online Sleep Monitoring Scale (COSMOS) 1.7. Physical fitness: A series of questionnaires and tasks designed to give a robust measure of current physical fitness. This involves: 1.8. Video-led tasks: Participants will view a video that will lead them through three simple tests of physical fitness which are validated for use in older age groups. This involves: 1.8.1. The Chair Stand Test, in which the participant raises from sitting to standing as many times as they can within 30 seconds, and provides the number of times, how difficult they found it and whether they used their hands to stand up 1.8.2. The Timed Chair-Stand Test, in which the participant reports how long it takes for them to rise from sitting to standing ten times 1.8.3. Two-Minute Step Test, in which the participant reports how many times they can march on the spot in 2 minutes 1.9. Self-Reported Gait Velocity: Participants rank their walking speed using a tick-box selection. This is validated for self-report. 1.10. The Activities-specific-Balance-Confidence (ABC) scale: A widely used 16-item measure for measuring balance in older adults. 2. Epigenetic sampling and processing: Participants will receive two saliva sample kits in the post. One will be sent after the baseline assessment and one prior to | — |
Countries
England, United Kingdom
Contacts
Public ContactAnne Corbett
Outcome results
None listed