Diet Quality, Time-restricted Eating
Conditions
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.
Interventions
OTHERTime-restricted eating
Time restricted eating for a self-selected 9 hour window per day
Best practice guidelines to improve diet quality
Sponsors
Australian Catholic University
La Trobe University
University of Adelaide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | baseline, 4 months | Glycated haemoglobin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal glucose | baseline, 4 months | AUC of glucose assessed by CGM from midnight to 0400 |
| HbA1c | 12 months | Glycated haemoglobin concentration |
| Fasting blood glucose | baseline, 4 months, 12 months | fasting blood glucose concentrations |
| Fasting insulin | baseline, 4 months, 12 months | fasting insulin concentrations |
| HOMA-IR | baseline, 4 months, 12 months | HOMA-IR |
Other
| Measure | Time frame | Description |
|---|---|---|
| hs-CRP | baseline, 4 months, 12 months | high sensitivity C-reactive protein (hs-CRP) |
| Liver markers | baseline, 4 months, 12 months | alanine transaminase (ALT) and aspartate aminotransferase (AST) |
| 24h assessment of glycaemia | baseline, 4 months | 24h glucose measures assessed by CGM (including, but not limited to, time in range, CV) |
| Physical activity | baseline, 4 months, 12 months | Components of activity (Step count, time in bed) assessed by inclinometer |
| Sleep duration | baseline, 4 months, 12 months | Sleep duration calculated from self-reported sleep/wake times |
| Cardiovascular measures | baseline, 4 months, 12 months | blood pressure and heart rate assessed using automated sphygmomanometer |
| meal timing / eating window | baseline, 4 months, 12 months | duration of eating window and individual meal times calculated from time-stamped food photos and/or self-reported meal times |
| Per protocol analysis | 4 months, 12 months | Per protocol analysis of data from participants who self-report adherence as 5-6 days per week or every day at 3.5 and 4 month adherence questionnaires (adherent to the protocol) |
| Adherence | 3.5, 4, 11.5, 12 months | measures of adherence assessed by self-report (questionnaire) |
| Chronotype | baseline, 3.5, 4, 11.5, 12 months | participant chronotype calculated from MEQ-SA questionnaire |
| TRE vs CP on ambulatory blood pressure and renal function (sub-study) | baseline, 4 months | Day and night time blood pressure (systolic, diastolic), dipping, morning surge, heart rate, blood pressure and heart rate variability. mesor, phase and amplitude of 24 hour ambulatory blood pressure monitoring; change in eGFR, creatinine, albumin urinary albumin:creatinine ratio, blood urea nitrogen and C-RP |
| TRE vs CP on CGM outcomes in a subset of individuals with pre-diabetes (sub-study) | 4 months, 12 months | Change in CGM metrics (including 2 hour at-home glucose challenge) in participants with HbA1c \>5.7% at baseline |
| TRE vs CP on quality of life, mood, sleep and food preferences (sub-study) | 4 months, 12 months | Assessment of lifestyle using AQOL, mood using DASS-21 and CIA, sleep using PSQI and food preferences using NQOL and DRQOL |
| TRE vs CP on diet quality (sub-study) | 4 months, 12 months | Assessment of changes in diet quality in TRE vs CP groups over 12 months using HEIFA (Healthy eating index for Australian Adults) |
| TRE vs CP on barriers and enablers of adherence (sub-study) | 4 months, 12 months | Qualitative interview of a subset of participants to identify barriers and enablers of adherence to TRE vs CP advice |
| Dietary intake | baseline, 4 months, 12 months | energy and macronutrient composition calculated from food diaries (research food diary app) |
| Body weight | baseline, 4 months, 12 months | body weight (assessed after an overnight fast, in a hospital gown) |
| Body composition | baseline, 4 months, 12 months | components of body composition assessed by DXA: fat mass (as percent body fat and kg), fat free mass (FFM, kg), visceral adipose tissue (VAT, g) and bone mass (kg) |
| Waist circumference | baseline, 4 months, 12 months | waist circumference (cm) |
| Hip circumference | baseline, 4 months, 12 months | hip circumference (cm) |
| Blood lipids | baseline, 4 months, 12 months | total, HDL and LDL cholesterol and triglycerides |
Countries
Australia
Outcome results
None listed