None listed
Conditions
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.
Interventions
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 depend
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.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
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. Participants aged 20 – 75 years 2. Body mass index greater than 20 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. Proteinuria (urinary albumin to creatinine ratio >30 mg/mmol) and impaired renal function eGFR<60 10. Malignancy in the past 2 years (other than nonmelanoma) and currently receiving active treatment 11. 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) 12. History of/or current eating disorder 13. Food allergies, or food aversions that prevent participants consuming key Mediterranean foods 14. Pregnant and/or currently breastfeeding
Outcome results
None listed