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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04762251
Other study ID # 14023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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