PMID- 34836715
OWN - NLM
STAT- MEDLINE
DCOM- 20220310
LR  - 20220311
IS  - 1590-3729 (Electronic)
IS  - 0939-4753 (Linking)
VI  - 32
IP  - 1
DP  - 2022 Jan
TI  - The rationale and design of a Mediterranean diet accompanied by time restricted 
      feeding to optimise the management of type 2 diabetes: The MedDietFast randomised 
      controlled trial.
PG  - 220-230
LID - S0939-4753(21)00471-3 [pii]
LID - 10.1016/j.numecd.2021.09.031 [doi]
AB  - BACKGROUND AND AIMS: Substantial scientific evidence supports the effectiveness 
      of a Mediterranean diet (MedDiet) in managing type 2 diabetes mellitus (T2DM). 
      Potential benefits of time restricted feeding (TRF) in T2DM are unknown. The 
      MedDietFast trial aims to investigate the efficacy of a MedDiet with or without 
      TRF compared to standard care diet in managing T2DM. METHODS AND RESULTS: 120 
      adults aged 20-75 with a body mass index (BMI) of 20-35 kg/m(2) and T2DM will be 
      randomised in a 3-arm parallel design to follow an ad libitum MedDiet with or 
      without 12-h TRF or the standard Australian Dietary Guidelines (ADG) for 24 
      weeks. All groups will receive dietary counselling fortnightly for 12 weeks and 
      monthly thereafter. The primary outcome is changes in HbA1c from baseline to 12 
      and 24 weeks. Secondary outcomes include fasting blood glucose, insulin, blood 
      lipids, weight loss, insulin resistance index (HOMA), Glucagon-like peptide 1 
      (GLP-1) and high-sensitivity C- reactive protein (hs-CRP). Data on medical 
      history, anthropometry, wellbeing, MedDiet adherence and satiety will be measured 
      at a private clinic via self-report questionnaires at baseline, 6, 12 and 24 
      weeks. Additionally, specimens (blood, urine and stool) will be collected at all 
      time points for future omics analysis. CONCLUSION: The MedDietFast trial will 
      examine the feasibility and effectiveness of a MedDiet with/without TRF in T2DM 
      patients. Potential synergistic effects of a MedDiet with TRF will be evaluated. 
      Future studies will generate microbiomic and metabolomic data for translation of 
      findings into simple and effective management plans for T2DM patients. TRIAL 
      REGISTRATION: Australia and New Zealand Clinical Trials Register, 
      ACTRN12619000246189.
CI  - Copyright (c) 2021 The Italian Diabetes Society, the Italian Society for the Study 
      of Atherosclerosis, the Italian Society of Human Nutrition and the Department of 
      Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. 
      All rights reserved.
FAU - Papamichou, Dimitra
AU  - Papamichou D
AD  - School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC 3083, 
      Australia.
FAU - Panagiotakos, Demosthenes B
AU  - Panagiotakos DB
AD  - Department of Nutrition and Dietetics, School of Health Science and Education, 
      Harokopio University, Athens, Greece; Faculty of Health, University of Canberra, 
      Australia.
FAU - Holmes, Elaine
AU  - Holmes E
AD  - Australian National Phenome Centre, Health Futures Institute, Murdoch University, 
      Harry Perkins Building, Perth, WA 6150, Australia; Centre for Computational 
      Systems Medicine, Health Futures Institute, Murdoch University, Harry Perkins 
      Building, Perth, WA6150, Australia.
FAU - Koutsakis, Polychronis
AU  - Koutsakis P
AD  - Discipline of Information Technology, Media and Communications, Murdoch 
      University, NSW, 2217, Australia.
FAU - Katsoulotos, Hariklia
AU  - Katsoulotos H
AD  - St George Specialist Centre, Sydney, NSW, 2217, Australia.
FAU - Loo, Ruey L
AU  - Loo RL
AD  - Australian National Phenome Centre, Health Futures Institute, Murdoch University, 
      Harry Perkins Building, Perth, WA 6150, Australia; Centre for Computational 
      Systems Medicine, Health Futures Institute, Murdoch University, Harry Perkins 
      Building, Perth, WA6150, Australia.
FAU - Itsiopoulos, Catherine
AU  - Itsiopoulos C
AD  - School of Health and Biomedical Sciences, RMIT University, Bundoora, VIC 3083, 
      Australia. Electronic address: catherine.itsiopoulos@rmit.edu.au.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211007
PL  - Netherlands
TA  - Nutr Metab Cardiovasc Dis
JT  - Nutrition, metabolism, and cardiovascular diseases : NMCD
JID - 9111474
SB  - IM
MH  - Adult
MH  - Aged
MH  - Australia
MH  - *Diabetes Mellitus, Type 2/diagnosis/therapy
MH  - *Diet, Mediterranean
MH  - Fasting
MH  - Humans
MH  - *Insulin Resistance
MH  - Middle Aged
MH  - Young Adult
OTO - NOTNLM
OT  - Diabetes management
OT  - Diabetes mellitus
OT  - Intermittent fasting
OT  - Mediterranean diet
OT  - Mediterranean dietary pattern
OT  - Personalised nutrition
OT  - Time restricted feeding
COIS- Declaration of competing interest All authors declare no competing interest.
EDAT- 2021/11/28 06:00
MHDA- 2022/03/11 06:00
CRDT- 2021/11/27 05:28
PHST- 2021/06/10 00:00 [received]
PHST- 2021/09/07 00:00 [revised]
PHST- 2021/09/24 00:00 [accepted]
PHST- 2021/11/28 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2021/11/27 05:28 [entrez]
AID - S0939-4753(21)00471-3 [pii]
AID - 10.1016/j.numecd.2021.09.031 [doi]
PST - ppublish
SO  - Nutr Metab Cardiovasc Dis. 2022 Jan;32(1):220-230. doi: 
      10.1016/j.numecd.2021.09.031. Epub 2021 Oct 7.