Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001212842
Ethics application status
Approved
Date submitted
4/05/2021
Date registered
10/09/2021
Date last updated
10/09/2021
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The MEDENI Trial: A microbiome-targeted Mediterranean diet intervention in residential aged care to reduce frailty.
Scientific title
The MEDENI Trial: A microbiome-targeted Mediterranean diet intervention in residential aged care to reduce frailty.
Secondary ID [1] 303203 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MEDENI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 320333 0
Aged care 320334 0
Condition category
Condition code
Oral and Gastrointestinal 318253 318253 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 320142 320142 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a parallel crossover randomised controlled dietary trial conducted in a residential aged care setting. The intervention will be the consumption/exposure to a Mediterranean diet (MedDiet).

The aim of this study it to determine the effect of a MedDiet on intestinal microbiology, frailty, wellbeing and cardiovascular and cognitive health. The MedDiet is a prescribed diet containing 15-45 mL extra-virgin olive oil/d, abundant vegetables, fruit, nuts, legumes, and whole grains, as well as moderate fish, poultry, and dairy foods. MedDiet will replace standard breakfast and dinner, whilst the usual diet will remain for lunches.

The trial will include two arms:

Arm 1 (treatment): The MedDiet will be prescribed for a 4-week duration, followed by a 4-week washout, and then the control diet will be prescribed for 4 weeks.

Arm 2 (control): The control treatment - Habitual diet (HabDiet) - will be provided for a 4-week duration, followed by a 4-week washout, and then the MedDiet will be prescribed for 4 weeks.
The control treatment is the residents’ habitual diet. The menu (breakfast, lunch, dinner) is prepared and provided by the residential aged care facility (RACF).

For each arm, the diets will be prepared and provided by the residential aged care facility staff. Delivery of the diets will be face-to-face by the facility staff who are known to the residents. The trial will take place within the aged care facility, and preparation of the diet will occur in-house within the facility kitchen. The intervention will not be personalised, as individuals with clinically-indicated requirements relating to dietary composition (e.g. kidney disease, diabetes, food allergies) or preparation (e.g. severe dysphagia, gastric feeding), will be excluded from the trial, as will those receiving palliative care, and those who have a colostomy or ileostomy, or severe gastrointestinal disease. However, the MedDiet may be adapted for the aged care study population to ensure sufficient variation and participation choice.

Adherence to all diets will be monitored using menu checklists, including percentage of meal consumed, number of eating occasions in a day, and number of days participated.
Intervention code [1] 319503 0
Prevention
Intervention code [2] 319504 0
Lifestyle
Comparator / control treatment
The control diet will be the participants usual, habitual diet (HabDiet). This will consist of the menu developed and provided by the RACF. The menu provides breakfast, lunch and dinner. Residents are able to consume their own food not prepared by the RACF. The menu developed by the RACF is not a designed Mediterranean theme, but is a Westernised-style diet. The HabDiet will be provided for a 4-week duration, followed by a 4-week washout, and then the MedDiet will be prescribed for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 326242 0
Relative (within-subject) change in faecal microbiota composition through comparison of pre- to post-intervention weighted UniFrac distance.

Specifically, change in the relative abundance of 44 discrete bacterial taxa known to be predictive of response to MedDiet in senior populations. The major taxa include Faecalibacterium prausnitzii, Roseburia (R. hominis), Eubacterium (E. rectale, E. eligens, E. xylanophilum), Bacteroides thetaiotaomicron, Prevotella copri and Anaerostipes hadrus, Ruminococcus torques, Collinsella aerofaciens, Coprococcus comes, Dorea formicigenerans, Clostridium ramosum, Veillonella dispar, Flavonifractor plautii and Actinomyces lingnae.
Microbiota composition will be defined using 16S rRNA gene amplicon analysis in an established analytical pipeline.
Timepoint [1] 326242 0
Stool samples will be collected at day 0 (baseline), 28, 56, and 84 (from trial commencement). Day 84 (at the conclusion of the second diet) will be the primary outcome endpoint.
Secondary outcome [1] 390711 0
Changes in weight measurements.
Timepoint [1] 390711 0
Weights will be measured at day 0 (baseline), 28, 56, and 84 (from trial commencement) with digital scales.
Secondary outcome [2] 390712 0
Changes in waist measurements
Timepoint [2] 390712 0
Waist circumference will be measured at day 0 (baseline), 28, 56, and 84 (from trial commencement) with a tape measure.
Secondary outcome [3] 397231 0
Changes in hip measurements
Timepoint [3] 397231 0
Hip circumference will be measured at day 0 (baseline), 28, 56, and 84 (from trial commencement) with a tape measure.
Secondary outcome [4] 397232 0
Changes in stool characteristics.
Timepoint [4] 397232 0
Stool characteristics will be assessed using the Bristol Stool Score in conjunction with the stool sample collection at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [5] 397233 0
Change in serum markers as assessed by blood sample.

Examples of markers screened include LDL, and HDL cholesterol, triglycerides, glucose, and insulin.
Timepoint [5] 397233 0
Blood samples will be collected at day 0 (baseline), 28, 56, and 84 (from trial commencement) via venepuncture following overnight fasting.
Secondary outcome [6] 397239 0
Change in blood pressure.
Timepoint [6] 397239 0
Blood pressure will be measured at day 0 (baseline), 28, 56, and 84 (from trial commencement) using a blood pressure monitor (sphygomomanometer).
Secondary outcome [7] 397240 0
Change in quality of life.
Timepoint [7] 397240 0
Quality of life will be determined using the Assessment of Quality of Life (AQoL-8D) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [8] 397241 0
Change in mood.
Timepoint [8] 397241 0
Mood will be evaluated using the Bond-Lader Visual Analogue Mood Rating Scale (BL-VAS) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [9] 397242 0
Change in depression symptoms.
Timepoint [9] 397242 0
Depression in participants will be measured using the Geriatric Depression Scale (GDS) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [10] 397243 0
Change in short-term mood.
Timepoint [10] 397243 0
Mood will be profiled using the Profile of Mood States (POMS) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [11] 397244 0
Change in sleep quality.
Timepoint [11] 397244 0
Sleep quality will be assessed using the Sleep Quality Index (SQI) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [12] 397245 0
Change in quality of social relationships.
Timepoint [12] 397245 0
Social networking quality will be assessed using the Social Network Index (SNI) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [13] 397246 0
Change in frailty status.
Timepoint [13] 397246 0
Frailty will be determined using the FRAIL Scale at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [14] 397247 0
Change in malnutrition status.
Timepoint [14] 397247 0
Extent of malnutrition will be determined using the Malnutrition Assessment (MNA) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [15] 397248 0
Change in short-term memory and cognition.
Timepoint [15] 397248 0
Memory and cognition will be measured using the Corsi Block Tap Test at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [16] 397249 0
Change in overall gastrointestinal health.
Timepoint [16] 397249 0
Gastrointestinal health will be measured using the Gastrointestinal Health Questionnaire (GHQ) at day 0 (baseline), 28, 56, and 84 (from trial commencement).
Secondary outcome [17] 400140 0
Change in serum inflammatory markers, including high-sensitivity C-reactive protein, tumor necrosis factor alpha, interleukin 1b, and interleukin 6, as assessed by enzyme-linked immunosorbent assay (ELISA) of blood samples
Timepoint [17] 400140 0
Blood samples will be collected at day 0 (baseline), 28, 56, and 84 (from trial commencement) via venepuncture following overnight fasting.

Eligibility
Key inclusion criteria
1. Long-term residents (greater than 6 months) of an aged care facility.
2. Informed consent.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Residents with clinically-indicated requirements relating to dietary composition (e.g. kidney disease, diabetes, food allergies) or preparation (e.g. severe dysphagia, gastric feeding), receiving palliative care, have a colostomy or ileostomy, or severe gastrointestinal disease, will be excluded.
2. Unable or unwilling to consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on published data (Casals-Pascual C, González A, Vázquez-Baeza Y, et al. Microbial Diversity in Clinical Microbiome Studies: Sample Size and Statistical Power Considerations. Gastroenterology. 2020 May;158(6):1524-1528.), inclusion of 25 subjects will provide 80% power to a 0.05 unit difference in our primary outcome, UniFrac distance between microbiota composition at the start and end of intervention and control arms. In order to account for a non-completion rate of approximately 15%, a total of 30 individuals will be recruited.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2021
Actual
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307605 0
Charities/Societies/Foundations
Name [1] 307605 0
Hospital Research Foundation
Country [1] 307605 0
Australia
Funding source category [2] 307614 0
Government body
Name [2] 307614 0
Department of Health
Country [2] 307614 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 308297 0
University
Name [1] 308297 0
The University of South Australia
Address [1] 308297 0
Corner of North Terrace and Frome Rd,
Adelaide SA 5001
Country [1] 308297 0
Australia
Secondary sponsor category [2] 308305 0
University
Name [2] 308305 0
Flinders University
Address [2] 308305 0
Sturt Rd, Bedford Park SA 5042
Country [2] 308305 0
Australia
Other collaborator category [1] 281596 0
Individual
Name [1] 281596 0
Professor Maria Crotty
Address [1] 281596 0
Flinders Medical Centre
Sturt Rd
Bedford Park
SA 5042
Country [1] 281596 0
Australia
Other collaborator category [2] 281597 0
Individual
Name [2] 281597 0
Associate Professor Karen Murphy
Address [2] 281597 0
University of South Australia
City East Campus
Corner of North Terrace and Frome Rd
Adelaide SA 5001
Country [2] 281597 0
Australia
Other collaborator category [3] 281598 0
Individual
Name [3] 281598 0
Professor Steve Wesselingh
Address [3] 281598 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country [3] 281598 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307977 0
University of South Australia HREC
Ethics committee address [1] 307977 0
Ethics committee country [1] 307977 0
Australia
Date submitted for ethics approval [1] 307977 0
09/03/2021
Approval date [1] 307977 0
02/06/2021
Ethics approval number [1] 307977 0
203767

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108038 0
Prof Geraint Rogers
Address 108038 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country 108038 0
Australia
Phone 108038 0
+61 08 8204 7614
Fax 108038 0
Email 108038 0
[email protected]
Contact person for public queries
Name 108039 0
Karen Murphy
Address 108039 0
University of South Australia
CEA-19
GPO Box 2471
Adelaide
SA 5001
Country 108039 0
Australia
Phone 108039 0
+61 8 83021033
Fax 108039 0
Email 108039 0
[email protected]
Contact person for scientific queries
Name 108040 0
Geraint Rogers
Address 108040 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
PO Box 11060, Adelaide SA 5001
Country 108040 0
Australia
Phone 108040 0
+61 08 8204 7614
Fax 108040 0
Email 108040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only summary group data will be available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.