None listed
Conditions
Brief summary
While dietary modification is a proven method to improve glycaemic control, the magnitude of improvement is reliant on diet adherence. The proposed study will investigated the feasibility of integrate a practical strategy (time-restricted eating) that may induce improvements in glycaemic control for individuals with type 2 diabetes (T2D).
Interventions
Participants will be asked to complete four weeks of time-restricted eating (TRE) where their energy intake (including caffeine but excluding water) is reduced to only between 10 am and 7 pm. To do this, participants will attend weekly meetings with the primary investigator, will use the Easy Diet Diary app to log their energy intake, 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 e
Participants will be asked to complete four weeks of time-restricted eating (TRE) where their energy intake (including caffeine but excluding water) is reduced to only between 10 am and 7 pm. To do this, participants will attend weekly meetings with the primary investigator, will use the Easy Diet Diary app to log their energy intake, 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 onwards will be photographed). Adherence will be measured through the total eating duration over each weekday and weekend day, with participants encouraged to adhere to the 9 hour limit (i.e. 10 am to 7 pm) on as many days of the week as possible.
Sponsors
Dr Evelyn Parr
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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% - 9%, 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
• Not a regular breakfast consumer; • 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); • 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; • Antibiotic use in previous 3 months.
Outcome results
None listed