Status:
COMPLETED
What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Lead Sponsor:
University of Adelaide
Collaborating Sponsors:
Australian Catholic University
La Trobe University
Conditions:
Time-restricted Eating
Diet Quality
Eligibility:
All Genders
35-70 years
Phase:
NA
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 Resear...
Detailed Description
In a parallel groups design, a total of 268 individuals will be recruited across both sites. After a 2-week baseline period, and a baseline metabolic visit, participants will be randomized into one of...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT04762251
Start Date
February 17 2021
End Date
April 19 2024
Last Update
August 2 2024
Active Locations (2)
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1
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia
2
Mary Mackillop Institute for Health Research
Melbourne, Victoria, Australia