None listed
Conditions
Brief summary
The proposed study will be the first to compare the benefits of TRE for improving glycaemic control compared with standard dietetic advice, in individuals with T2D in a chronic (6 months) randomised controlled trial. Evidence-based findings for the improvement of blood glucose control and longer term outcomes need to be developed in order for this information to be available for the design of larger studies, prior to being incorporated into current dietary guidelines and inform best practice. The combination of physiological and psychosocial measures will allow us to demonstrate the efficacy and safety of using TRE in a real-world setting to reduce the psychological burden of dietary modifications, whilst improving glycaemic control, for individuals with type 2 diabetes.
Interventions
Participants randomly allocated to the time-restricted eating group (TRE) will be asked to follow a time-restricted eating pattern (TRE) where they will be asked to reduce their energy intake to 9 hours (finishing eating no later than 7:30 pm) on as many days of the week as possible for the duration of the 6-month intervention. Participants will attend four x 30-45-minute consults, similar to general practitioner (GP) or health nurse check-ups, with a researcher who will provide advice regarding
Participants randomly allocated to the time-restricted eating group (TRE) will be asked to follow a time-restricted eating pattern (TRE) where they will be asked to reduce their energy intake to 9 hours (finishing eating no later than 7:30 pm) on as many days of the week as possible for the duration of the 6-month intervention. Participants will attend four x 30-45-minute consults, similar to general practitioner (GP) or health nurse check-ups, with a researcher who will provide advice regarding strategies to adhere to the altered timing of eating only. Consults will be scheduled for the beginning of the intervention, and after 1, 2 and 4 months of the intervention. During pre-determined monitoring periods, participants will record their dietary intake using the Research Food Diary app, or standard written food diaries, and will take photos with their smart phone to capture the time that they have eaten their meals (especially the first and last eating occasion; i.e. anything from dinner onward will be photographed). Adherence will be measured through calculating the total eating duration over each weekday and weekend day, with participants encouraged to adhere to the 9-hour limit (e.g. 9 am to 6:30 pm or 10:30 am to 7:30 pm) on as many days of the week as possible.
Sponsors
Dr Evelyn Parr
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Aged 35 to 65 years old • Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 10%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas) • Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures) • Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)
Exclusion criteria
• Does not have a smart phone or cannot operate the camera function on a smart phone; • Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period). • Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic); • Currently seeing or within 1 month of seeing a dietitian; • Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year); • Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year)) • Not weight stable (>5 kg change over last 3 months); • On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months; • Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting; • Women who are pregnant, breastfeeding (within 24 wk); • History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression) • Psychopharmacological treatment that has not been stable for more than 3 months; • Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids); • Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption.
Outcome results
None listed