None listed
Conditions
Brief summary
Hypothesis: Prolonging the overnight fast (i.e. missing the breakfast meal) has negative effects on blood sugars throughout the day The two intervention arms are: 1. Normal fasting period (i.e. breakfast, lunch and dinner provided) 2. Prolonged fasting period (i.e. breakfast omitted, only lunch and dinner provided) Both intervention arms comprise 2 days: Day 1: The participant arrives fasted. A continuous glucose monitor (CGM) is fitted, and an indwelling venous cannula inserted into the forearm. Blood samples are collected at baseline, and throughout a 3h period following each meal. Breakfast, lunch, and dinner will be given at 0845h, 1245h, 1745h; respectively at HNU. At the end of Day 1 the participant returns home with the CGM in situ. Day 2: Participants consume a standardised breakfast, lunch and dinner at home, and blood glucose is assessed by CGM. Day 3-4: Wash-out period Day 5: The participant arrives fasted. A continuous glucose monitor (CGM) is fitted, and an indwelling venous cannula inserted into the forearm. Blood samples are collected at baseline, and throughout a 3h period following each meal. No breakfast will be given; but lunch, and dinner will be given at 1245h, 1745h; respectively at HNU. At the end of Day 5, the participant returns home with the CGM in situ. Day 6: Participants consume a standardised breakfast, lunch and dinner at home, and blood glucose is assessed by CGM. The CGM remains in situ and is removed at the end of the 6 day study
Interventions
Participants will come to the Human Nutrition Unit (University of Auckland) fasted. This study is of a cross-over design and thus participants will need to come on two separate occasions within a 6-day period.
Day 1 (Human Nutrition Unit): Participants will be given breakfast, lunch, and dinner. Blood glucose, insulin, and free fatty acids will taken after each meal at set time points (up to 180 mins). [Intervention Arm 1]
Day 2 (home): Participants are given breakfast, lunch and dinner to eat a
Participants will come to the Human Nutrition Unit (University of Auckland) fasted. This study is of a cross-over design and thus participants will need to come on two separate occasions within a 6-day period. Day 1 (Human Nutrition Unit): Participants will be given breakfast, lunch, and dinner. Blood glucose, insulin, and free fatty acids will taken after each meal at set time points (up to 180 mins). [Intervention Arm 1] Day 2 (home): Participants are given breakfast, lunch and dinner to eat at home (same meals as day before). Participants will be monitored via a continuous glucose monitoring system Day 3: wash-out Day 4: wash-out Day 5 (Human Nutrition Unit): Participants will not be given breakfast, but lunch and dinner. Blood glucose, insulin, and free fatty acids will taken after each meal at set time points (up to 180 mins). [Intervention Arm 2] Day 6 (home): Participants are given breakfast, lunch and dinner to eat at home. Participants will be monitored via a continuous glucose monitoring system Order of treatment will be determined by randomisation. Each clinic day will be approximately 10 hours. Each participant will wear the continuous glucose monitor for the entire 6-day period. Breakfast, lunch, and dinner will be given at 0845h, 1245h, 1745h; respectively at HNU. Participants will be asked to consume meals at the same time when they are at work/home. All meals will be 3MJ, ~55% carbohydrate, ~25% fat, ~15% protein, ~3-5% fibre. Intervention adherence will be assessed via the CGMS. A log will be provided with the CGMS, to record calibration measurements, food intake, medications, and activity. If outliers are present in the CGMS data (due to poor compliance), the participant may be asked to repeat the intervention.
Sponsors
University of Auckland School of Biological Sciences
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Overweight/obese (BMI 28-35kg/m2) Diagnosed with Type 2 diabetes (diet controlled or on Metformin only) Aged 40-60 years
Exclusion criteria
Diagnosed with type 1 diabetes, or other metabolic disorder ·Sulfonylurea, insulin or other diabetic therapies Any diagnosed digestive or malabsorptive disorder
Outcome results
None listed