The effects of Mediterranean diet with or without intermittent fasting in Type 2 Diabetes (the MedDietFast trial)

Not Applicable

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000246189
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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]

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c assessed by using serum essay analysis performed in a qualified laboratory.[Timepoint: Baseline, 3 months (primary timepoint) and 6 months after intervention commencement]