Phase
Condition
N/ATreatment
Time-restricted eating
Current Best Practice
Clinical Study ID
Ages 35-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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, bipolardisorder, 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 toscreening
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 orDPP-IV inhibitors [i.e. 'gliptins'])
Medications affecting weight, appetite or gut motility, including, but not limitedto: (domperidone, cisapride, orlistat, phentermine, topiramate).
Diuretics (i.e. frusemide, thiazides) or combination blood pressure medicationscontaining a diuretic
Beta-blockers
Glucocorticoids
Anti-epileptic medications
Antipsychotic medications
Opioid medications unless combined with paracetamol in a single formulation and usedoccasionally on a PRN basis
Additional exclusion criteria include:
do not consume a regular breakfast (i.e. eat breakfast on an average of 5 or moredays per week), and do not eat for more than 12 hours per day on an average of 5 ormore days per week
have an extreme or restricted pattern of eating (i.e. following an intermittentfasting 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. dueto 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)
Study Design
Study Description
Connect with a study center
South Australian Health and Medical Research Institute
Adelaide, South Australia
AustraliaSite Not Available
Mary Mackillop Institute for Health Research
Melbourne, Victoria
AustraliaSite Not Available
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