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

RMIT University0 个研究点目标入组 120 人开始时间: 2019年2月19日最近更新: 2022年8月9日

适应症

试验速览

暂无简介。

•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]

•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

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