What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)

Brief Summary

A parallel, single-blinded, multi-centre randomized controlled trial conducted at the South Australian Health and Medical Research Institute (SAHMRI) and the Mary Mackillop Institute for Health Research (MMIHR; Australian Catholic University), by researchers from the University of Adelaide, Australian Catholic University and La Trobe University.

Key Inclusion Criteria

Inclusion Criteria: * Study participants will be aged 35 to 70 years, overweight or obese (BMI: >25 but <45 kg/m2), =15 on the AUSDRISK assessment tool and have HbA1c <6.5% at screening Exclusion Criteria: Type 1 or type 2 diabetes, or diabetes detected at screening HbA1c =6.5% (48 mmol/mol). * A personal history/diagnosis (self-reported) of: * major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders) * gastrointestinal disorders/disease (includin .... Inclusion Criteria: * Study participants will be aged 35 to 70 years, overweight or obese (BMI: >25 but <45 kg/m2), =15 on the AUSDRISK assessment tool and have HbA1c <6.5% at screening Exclusion Criteria: Type 1 or type 2 diabetes, or diabetes detected at screening HbA1c =6.5% (48 mmol/mol). * A personal history/diagnosis (self-reported) of: * major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders) * gastrointestinal disorders/disease (including malabsorption) * haematological disorders (i.e. thalassemia, iron-deficiency anaemia) * insomnia * currently receiving, or have received treatment/diagnosis of cancer in the past 3 years (excluding non-melanoma skin cancer) * significant liver or kidney disease * previous or planned gastro-intestinal surgery (including bariatric surgery) * Congestive heart failure (NYHA stage 2 or above) * Previous myocardial infarction or significant cardiac event = 6 months prior to screening * Previous cerebrovascular event = 12 months prior to screening and/or any other condition deemed unstable by the study physician. Currently taking the following medications: * any medication used, or known to lower blood glucose, or antidiabetic medications, including, but not limited to: SGLT2 inhibitors, metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']) * Medications affecting weight, appetite or gut motility, including, but not limited to: (domperidone, cisapride, orlistat, phentermine, topiramate). * Diuretics (i.e. frusemide, thiazides) or combination blood pressure medications containing a diuretic * Beta-blockers * Glucocorticoids * Anti-epileptic medications * Antipsychotic medications * Opioid medications unless combined with paracetamol in a single formulation and used occasionally on a PRN basis Additional exclusion criteria include: * do not consume a regular breakfast (i.e. eat breakfast on an average of 5 or more days per week), and do not eat for more than 12 hours per day on an average of 5 or more days per week * have an extreme or restricted pattern of eating (i.e. following an intermittent fasting diet) or are already engaged in a TRE protocol * shift-workers * pregnant, planning a pregnancy or currently breastfeeding * those who have lost or gained >5% of body weight in the last 6 months * current smokers of cigarettes/marijuana/e-cigarettes/vaporisers * anyone unable to comprehend the study protocol or provide informed consent (i.e. due to English language or cognitive difficulties) * Participants will not have seen a dietitian in the preceding 3 months. * score on K10 =30 (Kessler Psychological Distress scale) * score on EDEQ =2.8 (Eating Disorder Examination Questionnaire) Read more

Key Exclusion Criteria

Can healthy volunteers participate?

Accepts Healthy Volunteers