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Time-restricted EatingNCT04762251

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

A study testing Time-restricted eating and Current Best Practice in people with Time-restricted Eating and Diet Quality, run by University of Adelaide at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Time-restricted Eating, Diet Quality
What is being tested?
Time-restricted eating and Current Best Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
2 sitesAustralia
Study dates
17 Feb 2021to 19 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • South Australian Health and Medical Research Institute

    Adelaide, South Australia

  • Mary Mackillop Institute for Health Research

    Melbourne, Victoria

Other trials in Australia

About this study

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.

Read the 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.

Being tested
Time-restricted eating, Current Best Practice
Medical subject headings
Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-restricted eatingOther

    Time restricted eating for a self-selected 9 hour window per day

  • Current Best PracticeOther

    Best practice guidelines to improve diet quality

Study groups in NCT04762251
Study groupRoleWhat they receive
Time-restricted eating (TRE)ExperimentalThe TRE group will be instructed to follow TRE (9 h/day) every day for 12 months with no other dietary instructions or advice provided. The TRE group will attend the same consult schedule as the CP group, but consultations will focus on timing of dietary intake and strategies to promote adherence. No dietary guidance regarding quantity or quality will be provided. Participants will be able to self-select the precise 9-h schedule that will best suit their lifestyles, with the caveat that the latest time of eating will be set at 7:00 pm. Outside of the elected eating window, participants will be allowed to consume water and black coffee and/or tea.
Receives: Other: Time-restricted eating
Current Best Practice (CP)Active comparatorThis group is designed to act as a comparator using 'standard care' in dietetics practice. Dietary advice provided to this participant group will be performed by Accredited Practicing Dietitians (APDs) in line with evidence-based guidelines, specifically the T2DM best-practice guidelines plus Australian Dietary Guidelines (i.e. Australian Guide to Healthy Eating) to improve diet quality, and strategies to promote adherence. No specific advice will be provided regarding time of day to start and finish eating and/or drinking (since this information is not outlined in current practice guidelines).
Receives: Other: Current Best Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Glycated haemoglobin concentration

    Measured: baseline, 4 months

Secondary outcomes (5)

  1. HbA1c

    Glycated haemoglobin concentration

    Measured: 12 months

  2. Fasting blood glucose

    fasting blood glucose concentrations

    Measured: baseline, 4 months, 12 months

  3. Fasting insulin

    fasting insulin concentrations

    Measured: baseline, 4 months, 12 months

  4. HOMA-IR

    HOMA-IR

    Measured: baseline, 4 months, 12 months

  5. Nocturnal glucose

    AUC of glucose assessed by CGM from midnight to 0400

    Measured: baseline, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start17 Feb 2021
  3. Primary completion2 Aug 2023
  4. Study completion19 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762251
Sponsor's protocol ID
14023
Status last verified
Jul 2024
First submitted
16 Feb 2021
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publically available, as it contains information that could compromise research participant consent.

Publications

  • Parr EB, Charrouf R, Hutchison AT, Flint SA, Teong XT, Vincent AD, Bravo-Garcia AP, Siviour Z, Wittert GA, Brennan L, Devlin BL, Hawley JA, Heilbronn LK. Time-restricted eating versus dietetic guidance on glycaemic outcomes in adults at risk of type 2 diabetes: a non-inferiority randomised clinical trial. Diabetologia. 2026 Sep;69(9):2458-2471. doi: 10.1007/s00125-026-06762-x. Epub 2026 Jun 6.

    PubMed 42251202

  • Charrouf R, Parr EB, Hutchison AT, Flint SA, Teong XT, Wittert G, Vincent AD, Brennan L, Devlin BL, Hawley JA, Heilbronn LK. Effect of time restricted eating versus current practice in dietetics on glycaemic control and cardio-metabolic outcomes in individuals at risk of developing type 2 diabetes: Protocol for a multi-centre, parallel group, non-inferiority, randomised controlled trial. Contemp Clin Trials. 2024 Nov;146:107696. doi: 10.1016/j.cct.2024.107696. Epub 2024 Sep 17.

    PubMed 39299545

Questions about this trial

What is this clinical trial studying?

A study testing Time-restricted eating and Current Best Practice in people with Time-restricted Eating and Diet Quality, run by University of Adelaide at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: baseline, 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04762251, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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