None listed
Conditions
Brief summary
The overarching hypothesis is that a weight loss strategy using an intermittent fasting approach will be more efficacious than a conventional 30% calorie restricted diet approaches in the context of diabetes. The overall aim of the project is to compare the safety and metabolic effects of weight loss via an intermittent fasting protocol versus a standard daily calorie restriction protocol in overweight and obese adult subjects with type 1 and type 2 diabetes.
Interventions
Arm 1: 5:2 Diet – 2 consecutive days per week of calorie reduction to 600 calories per day (Optifast Registered Trademark meal replacement for the 3 main meal a day) followed by 5 days of eating to appetite.
Arm 2: Calorie Restriction Diet – moderate (30%) reduction of calories based on baseline energy requirements. This will be calculated for each participant using their weight, height, age, gender and will follow current Australian Dietary Guidelines. The advise will be provided in a 1 hour
Arm 1: 5:2 Diet – 2 consecutive days per week of calorie reduction to 600 calories per day (Optifast Registered Trademark meal replacement for the 3 main meal a day) followed by 5 days of eating to appetite. Arm 2: Calorie Restriction Diet – moderate (30%) reduction of calories based on baseline energy requirements. This will be calculated for each participant using their weight, height, age, gender and will follow current Australian Dietary Guidelines. The advise will be provided in a 1 hour session with a Registered Nurse at baseline. an example meal plan will be provided which will outline the breakdown of food serves. This will be based on the entries provided in a Food and Activity Diary which will be completed between the Screening and Randomisation visit. Participants from both groups will be monitored for hypoglycaemia, ketoacidosis and diabetes treatment will be adjusted as required by the Research team. Both diets will be followed for a 12 week period. During the treeatment period, adherence to the study diets will be monitored by way of a Food and Activity Diary which will be completed prior to each face-to-face study visit.
Sponsors
Associate Professor Jencia Wong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Type 1 or Type 2 Diabetes - Currently aged 18 years or older - Duration of diabetes > 1 year and familiar with diabetes self management principles - BMI between 25 and 35 kg/m2 or presence of the metabolic syndrome as defined by the International Diabetes Federation* *Waist circumference > 94 cm for Europid men and > 80 cm for Europid women, plus any two of the following four factors: ~ Triglyceride level >1.7 mmol/L (or specific treatment) ~ HDL cholesterol < 1.03 mmol/L in males and < 1.29 mmol/L in females (or specifc treatment) ~ Systolic blood pressure > 130 mmHg ~Diastolic blood pressure > 85 mmHg (or treatment of previously diagnoses hypertension)
Exclusion criteria
- HbA1c < 6.5% and > 10% - History of unconscious hypoglycaemia or diabetic ketoacidosis within the last 12 months - Known autonomic failure, hypoglycaemia unawareness, CVD, severe renal disease (eGFR < 30ml/min/BSA) and severe hepatic disease (synthetic dysfunction of LFT > 4 times ULN) - Use of steroids - Pregnancy or lactation - Documented history of eating disorder - Curernt treatment requires the use of pre-mixed insulin regimens
Outcome results
None listed