Clinical trial NCT04762251: What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Official title: What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time-restricted Eating
Diet Quality
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Australian Catholic University
name: La Trobe University
First posted: 2021-02-21
Enrollment: 247
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 two groups (TRE, time-restricted eating; CP, current practice guidelines). All participants will receive five (5) telehealth consultations at baseline, week 2, 4, 8 and 12, the content of which will be based around their randomized condition. They will undergo metabolic testing on two (2) further occasions (4 months, 12 months) over a 12-month period to assess the changes in primary and secondary outcomes.

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)

Primary outcomes:
measure: HbA1c
timeFrame: baseline, 4 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Fasting blood glucose
timeFrame: baseline, 4 months, 12 months
measure: Fasting insulin
timeFrame: baseline, 4 months, 12 months
measure: HOMA-IR
timeFrame: baseline, 4 months, 12 months
measure: Nocturnal glucose
timeFrame: baseline, 4 months
Other outcomes:
measure: Per protocol analysis
timeFrame: 4 months, 12 months
measure: Body weight
timeFrame: baseline, 4 months, 12 months
measure: Body composition
timeFrame: baseline, 4 months, 12 months
measure: Waist circumference
timeFrame: baseline, 4 months, 12 months
measure: Hip circumference
timeFrame: baseline, 4 months, 12 months
measure: Blood lipids
timeFrame: baseline, 4 months, 12 months
measure: hs-CRP
timeFrame: baseline, 4 months, 12 months
measure: Liver markers
timeFrame: baseline, 4 months, 12 months
measure: 24h assessment of glycaemia
timeFrame: baseline, 4 months
measure: Physical activity
timeFrame: baseline, 4 months, 12 months
measure: Sleep duration
timeFrame: baseline, 4 months, 12 months
measure: Cardiovascular measures
timeFrame: baseline, 4 months, 12 months
measure: meal timing / eating window
timeFrame: baseline, 4 months, 12 months
measure: Dietary intake
timeFrame: baseline, 4 months, 12 months
measure: Adherence
timeFrame: 3.5, 4, 11.5, 12 months
measure: Chronotype
timeFrame: baseline, 3.5, 4, 11.5, 12 months
measure: TRE vs CP on ambulatory blood pressure and renal function (sub-study)
timeFrame: baseline, 4 months
measure: TRE vs CP on CGM outcomes in a subset of individuals with pre-diabetes (sub-study)
timeFrame: 4 months, 12 months
measure: TRE vs CP on quality of life, mood, sleep and food preferences (sub-study)
timeFrame: 4 months, 12 months
measure: TRE vs CP on diet quality (sub-study)
timeFrame: 4 months, 12 months
measure: TRE vs CP on barriers and enablers of adherence (sub-study)
timeFrame: 4 months, 12 months
Locations:
city: Adelaide
country: Australia
facility: South Australian Health and Medical Research Institute
state: South Australia
city: Melbourne
country: Australia
facility: Mary Mackillop Institute for Health Research
state: Victoria
Study officials:
affiliation: University of Adelaide
name: Leonie Heilbronn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Australian Catholic University
name: John Hawley, PhD
role: PRINCIPAL_INVESTIGATOR
References: