Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04762251
Eligibility 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 (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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT04762251
Study Brief:
Protocol Section:
NCT04762251