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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Changes in HbA1c assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [1]

Timepoint: Baseline, 3 months (primary timepoint) and 6 months after intervention commencement

Secondary outcome [1]

Changes in fasting plasma glucose assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [1]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [2]

Changes in plasma insulin concentrations assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [2]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [3]

Changes in LDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [3]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [4]

Changes in systolic and diastolic blood pressure assessed using automated sphygmomanometry

Timepoint [4]

Timepoint: Baseline, and at 6 weeks, 3 months and 6 months after intervention commencement

Secondary outcome [5]

Changes in CRP assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [5]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [6]

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]

Timepoint: Baseline, and at 6 weeks, 3 months and 6 months after intervention commencement

Secondary outcome [7]

Changes in HDL cholesterol assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [7]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [8]

Changes in triglycerides assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [8]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [9]

Changes in total cholesterol assessed by using serum essay analysis performed in a qualified laboratory.

Timepoint [9]

Timepoint: Baseline, and at 3 and 6 months after intervention commencement

Secondary outcome [10]

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]

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?

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]

2217 - Kogarah

Recruitment postcode(s) [2]

2137 - Breakfast Point

Recruitment outside Australia

Country [1]

Greece

State/province [1]

ATTIKI ATHENS

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

N/A

Address [1]

N/A

Country [1]

Primary sponsor type

University

Name

RMIT University

Address

RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT University Human Research Ethics Commitee

Ethics committee address [1]

Research Integrity Governance and Systems
RMIT University
GPO Box 2476
MELBOURNE  VIC  3001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/05/2021

Approval date [1]

29/06/2021

Ethics approval number [1]

2021-24430-14772

Ethics committee name [2]

RMIT University Human Research Ethics Commitee

Ethics committee address [2]

Research Integrity Governance and Systems RMIT University GPO Box 2476 MELBOURNE VIC 3001

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

05/05/2022

Approval date [2]

Ethics approval number [2]

N/A

Ethics committee name [3]

RMIT University Human Research Ethics Committee

Ethics committee address [3]

Research Integrity Governance and Systems RMIT University GPO Box 2476 MELBOURNE VIC 3001

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

22/06/2022

Approval date [3]

Ethics approval number [3]

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

Prof Catherine Itsiopoulos

Address

RMIT University / Bundoora / Victoria 3083

Country

Australia

Phone

+61 03 9925 7395

Fax

Catherine.itsiopoulos@rmit.edu.au

Contact person for public queries

Name

Catherine Itsiopoulos

Address

RMIT University / Bundoora / Victoria 3083

Country

Australia

Phone

+61 3 9925 7395

Fax

Catherine.itsiopoulos@rmit.edu.au

Contact person for scientific queries

Name

Catherine Itsiopoulos

Address

RMIT University / Bundoora / Victoria 3083

Country

Australia

Phone

+61 3 99257395

Fax

Catherine.itsiopoulos@rmit.edu.au

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.	Type	Citation	Link	Email	Other Details	Attachment
1269	Study protocol					376809-(Uploaded-24-05-2021-11-47-07)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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