Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000246189
Ethics application status
Approved
Date submitted
5/02/2019
Date registered
19/02/2019
Date last updated
15/07/2022
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Mediterranean diet with or without intermittent fasting in Type 2 Diabetes (the MedDietFast trial)
Scientific title
The effects of Mediterranean diet with or without intermittent fasting in Type 2 Diabetes (the MedDietFast randomised controlled trial)
Secondary ID [1] 297184 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 311227 0
Condition category
Condition code
Metabolic and Endocrine 309854 309854 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
Intensive personalised dietary counseling based on a Mediterranean diet [low in saturated fat [<7% of total energy intake (TEI)] and high in fiber (>40g/day)], consumed ad libitum and delivered by a nutritionist with minimum 5 years' experience.
The duration of the intervention will be 6 months. Participants will have phone or video appointments with a nutritionist biweekly for 12 weeks and monthly thereafter to facilitate compliance.
Appointments will last between 45 to 60 minutes depending on clients needs and compliance with the intervention.
Adherence to the Mediterranean dietary pattern will be assessed from 7 consecutive days (including 2 weekend days) of daily weighed food records for every 14-day period.
Arm 2
Intensive personalised dietary counseling based on a Mediterranean diet [low in saturated fat (<7% of TEI) and high in fiber (>40g/day)], consumed ad libitum accompanied by time restricted feeding (12h fasting every day).
The intervention will be delivered by a nutritionist with minimum 5 years' experience.
The duration of the intervention will be 6 months. Participants will have phone or video appointments with a nutritionist biweekly for 12 weeks and monthly thereafter to facilitate compliance.
Appointments will last between 45 to 60 minutes depending on clients' needs and compliance with the intervention.
Adherence to the Mediterranean dietary pattern will be assessed from 7 consecutive days (including 2 weekend days) of daily weighed food records for every 14-day period.
The same intervention will apply in a cohort in Greece, where all appointments will be online.
Intervention code [1] 313447 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will receive intensive dietary counselling based on the Australian Dietary Guidelines for healthy eating fortnightly for 12 weeks and monthly thereafter. During these telephone appointments, the nutritionist will reinforce dietary counselling, behavioural change and address any potential challenges and issues that the participant is facing in adhering to the diets. Consultations will last between 45 to 60 minutes depending on clients needs and compliance with the intervention.
Control group
Active

Outcomes
Primary outcome [1] 318810 0
Changes in HbA1c assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [1] 318810 0
Timepoint: Baseline, 3 months (primary timepoint) and 6 months after intervention commencement
Secondary outcome [1] 366124 0
Changes in fasting plasma glucose assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [1] 366124 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [2] 366125 0
Changes in plasma insulin concentrations assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [2] 366125 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [3] 366126 0
Changes in LDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [3] 366126 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [4] 366127 0
Changes in systolic and diastolic blood pressure assessed using automated sphygmomanometry
Timepoint [4] 366127 0
Timepoint: Baseline, and at 6 weeks, 3 months and 6 months after intervention commencement
Secondary outcome [5] 366128 0
Changes in CRP assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [5] 366128 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [6] 366129 0
Medication changes assessed using a medication record at each visit, asking specifically if there were any changes to the medications or the dose taken.
Timepoint [6] 366129 0
Timepoint: Baseline, and at 6 weeks, 3 months and 6 months after intervention commencement
Secondary outcome [7] 366578 0
Changes in HDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [7] 366578 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [8] 366579 0
Changes in triglycerides assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [8] 366579 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [9] 366735 0
Changes in total cholesterol assessed by using serum essay analysis performed in a qualified laboratory.
Timepoint [9] 366735 0
Timepoint: Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [10] 396739 0
Changes in metabolites assessed by using blood, urine and stool samples through mass spectrometry performed in a qualified laboratory at the Australian National Phenome Centre
Timepoint [10] 396739 0
Baseline, 6 weeks, 3 months and 6 months

Eligibility
Key inclusion criteria
1. Informed consent
2. Diagnosed with Type 2 Diabetes [HbA1c greater than or equal to 6.5% (48 mmol/mol); or a fasting plasma glucose level greater than or equal to126 mg/dl (7.0 mmol/l) or; 2-hour post-challenge (oral glucose tolerance test) plasma glucose level greater than or equal to 200 mg/dl (11.1 mmol/l) and/or taking oral glycaemic medications]
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <20 or >75 years old
2. Body mass index <20 and >35 kg/m2
3. Unwillingness or inability to comply to the dietary intervention
4. Type 1 diabetes or taking insulin
5. Unstable diabetic control or changes in diabetes medication in the last 3 months prior the initiation of the trial.
6. Mediterranean Diet Adherence Score (MEDAS) greater than or equal to 9 [41]
7. Shift working
8. Eating duration greater than or equal to 12 h during the previous year and or regularly skip meals for dieting
9. Significant weight change of > 3kg over last 3 months
10. Prescribed a course of antibiotics in the preceding 2 months
11. Proteinuria (urinary albumin to creatinine ratio >30 mg/mmol) and impaired renal function eGFR<60
12. Malignancy in the past 2 years (other than nonmelanoma) and currently receiving active treatment
13. Active and uncontrolled liver, respiratory, gastrointestinal, cardiovascular disease, mental illness, endocrinopathy (other than stable treated thyroid disease) or inflammatory diseases (e.g. rheumatoid arthritis, Crohn’s disease, colostomy, malabsorption)
14. History of/or current eating disorder
15. Food allergies, or food aversions that prevent participants consuming key Mediterranean foods
16. Current Smoker
17. Pregnant and/or currently breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of n=96 patients (32 patients per group, for the three groups in the study) will be sufficient to detect a standardized effect size (eta squared) difference of 10% on the examined cases, with 80% power and a 5% significance level. Considering the possibility of 20% dropouts, an additional sample needs to be included. The sample size, therefore will need to be N=n/(1-0.2)=120 patients (40 patients per group).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25473 0
2217 - Kogarah
Recruitment postcode(s) [2] 34347 0
2137 - Breakfast Point
Recruitment outside Australia
Country [1] 21225 0
Greece
State/province [1] 21225 0
ATTIKI ATHENS

Funding & Sponsors
Funding source category [1] 301758 0
Self funded/Unfunded
Name [1] 301758 0
N/A
Country [1] 301758 0
Primary sponsor type
University
Name
RMIT University
Address
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Country
Australia
Secondary sponsor category [1] 301501 0
None
Name [1] 301501 0
Address [1] 301501 0
Country [1] 301501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302481 0
RMIT University Human Research Ethics Commitee
Ethics committee address [1] 302481 0
Research Integrity Governance and Systems
RMIT University
GPO Box 2476
MELBOURNE VIC 3001
Ethics committee country [1] 302481 0
Australia
Date submitted for ethics approval [1] 302481 0
14/05/2021
Approval date [1] 302481 0
29/06/2021
Ethics approval number [1] 302481 0
2021-24430-14772
Ethics committee name [2] 311029 0
RMIT University Human Research Ethics Commitee
Ethics committee address [2] 311029 0
Research Integrity Governance and Systems RMIT University GPO Box 2476 MELBOURNE VIC 3001
Ethics committee country [2] 311029 0
Australia
Date submitted for ethics approval [2] 311029 0
05/05/2022
Approval date [2] 311029 0
Ethics approval number [2] 311029 0
N/A
Ethics committee name [3] 311293 0
RMIT University Human Research Ethics Committee
Ethics committee address [3] 311293 0
Research Integrity Governance and Systems RMIT University GPO Box 2476 MELBOURNE VIC 3001
Ethics committee country [3] 311293 0
Australia
Date submitted for ethics approval [3] 311293 0
22/06/2022
Approval date [3] 311293 0
Ethics approval number [3] 311293 0

Summary
Brief summary
Main Goal & Objectives of the study
The objective of the present trial is associated with dietary interventions in the management of Type 2 Diabetes. The focus will be oriented towards the efficacy of the Mediterranean diet (MD) in the management of type 2 diabetes. The research hypothesis is whether a Mediterranean dietary pattern with or without intermittent fasting may better control diabetes, as compared with a conventional diet based on the current recommendations for patients with Type 2 diabetes. The objectives of the project are as follows; a. the superiority or non-inferiority of a MD accompanied by intermittent fasting vs. a MD and a conventional diet against Type 2 diabetes markers, b. the feasibility/sustainability of an intermittent fasting protocol, with moderate intensity, or standard healthy dietary patterns (i.e. Mediterranean, conventional diet) in patients with Type 2 Diabetes, c. the “clear” effect of “intermittent fasting” on diabetes markers, d. the design of an alternative dietary intervention for the management of diabetes mellitus, e. the reveal of more robust evidence regarding the effect of Mediterranean diet in the management of Type 2 diabetes and.
A major challenge for nutrition behavioral clinical trials is to suggest a dietary plan being not only in accordance with the recent literature tendency and showing promising results during the trials’ setting, but, most importantly, feasible to be adopted by the individuals in their daily life. The aim of the trial is to provide a feasible and sustainable guide to healthy eating, because it includes dietary guidelines based on the Mediterranean diet, combined with an innovative promising dietary protocol (Mediterranean diet accompanied by time restricted feeding), which can easily be adopted.
Intervention: The three arms of the clinical trial will be as follows; a. control group, b. low saturated fat (<7% of TEI), high fiber (>40g/day) MD (Intervention I) and c.MD accompanied by time restricted feeding (TRF) (Intervention II). The active trial duration will be 6 months with follow-up in 6 weeks, 3 months and 6 months since baseline.

We decided to add a Greek cohort as this will give information on the effectiveness and adherence of a Mediterranean diet in a Mediterranean population compared to a non-Mediterranean population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90294 0
Prof Catherine Itsiopoulos
Address 90294 0
RMIT University / Bundoora / Victoria 3083
Country 90294 0
Australia
Phone 90294 0
+61 03 9925 7395
Fax 90294 0
Email 90294 0
[email protected]
Contact person for public queries
Name 90295 0
Prof Catherine Itsiopoulos
Address 90295 0
RMIT University / Bundoora / Victoria 3083
Country 90295 0
Australia
Phone 90295 0
+61 3 9925 7395
Fax 90295 0
Email 90295 0
[email protected]
Contact person for scientific queries
Name 90296 0
Prof Catherine Itsiopoulos
Address 90296 0
RMIT University / Bundoora / Victoria 3083
Country 90296 0
Australia
Phone 90296 0
+61 3 99257395
Fax 90296 0
Email 90296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal, including meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1269Study protocol    376809-(Uploaded-24-05-2021-11-47-07)-Study-related document.docx



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.