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

Diet Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762251
• Other study ID #: 14023
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: January 11, 2025

Study information

• Verified date: March 2023
• Source: University of Adelaide
• Contact: Amy Hutchison, PhD
• Phone: 08 8128 4862
• Email: amy.hutchison[@]adelaide.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 University and La Trobe University.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: January 11, 2025
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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:

• A personal history/diagnosis (self-reported) of:

• diabetes (type 1 or 2)

• 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), OR 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.

Related Conditions & MeSH terms

• Diet Quality
• Time-restricted Eating

Intervention

Other:
• Time-restricted eating
Time restricted eating for a self-selected 9 hour window per day
• Current Best Practice
Best practice guidelines to improve diet quality

Locations

Country	Name	City	State
Australia	South Australian Health and Medical Research Institute	Adelaide	South Australia
Australia	Mary Mackillop Institute for Health Research	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
University of Adelaide	Australian Catholic University, La Trobe University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Glycated haemoglobin concentration	4 months
Secondary	HbA1c	Glycated haemoglobin concentration	12 months
Secondary	24-hour glucose variability	Assessment of 24 hour glucose variability by continuous glucose monitor	4 months
Secondary	Body weight	change in body weight	4 months, 12 months
Secondary	Body composition	change in percent body fat, fat free mass by DXA	4 months, 12 months
Secondary	Waist circumference	change in waist circumference	4 months, 12 months
Secondary	Hip circumference	change in hip circumference	4 months, 12 months
Secondary	Fasting blood glucose	Change in fasting blood glucose concentrations	4 months, 12 months
Secondary	Fasting insulin	Change in fasting insulin concentrations	4 months, 12 months
Secondary	Blood lipids	Change in total, HDL and LDL cholesterol and triglycerides	4 months, 12 months
Secondary	Physical activity	Changes in activity assessed by inclinometer	4 months, 12 months
Secondary	Adherence	measures of adherence assessed by self-report	0.5, 1, 2, 3, 4, 8, 12 months