None listed
Conditions
Brief summary
Standard treatment of gestational diabetes mellitus (GDM) involves a moderately reduced carbohydrate intake spread evenly across the day to reduce glucose spikes, regular moderate physical activity, finger prick glucose monitoring four times daily and where necessary insulin to control maternal glucose levels. Although improving lifestyle is the first-line treatment for GDM, there is no agreement for the best diet. This 21-day pilot randomised control crossover study will see if a low glycaemic load breakfast can improve daily glucose control, reduce the need for insulin and is safe and acceptable in women with GDM. The primary outcomes include measures of glycaemic variability including time in range, time below the range and time above the range, Secondary outcomes include maternal metabolic parameters (fasting lipids and beta-hydroxybutyrate).
Interventions
Breakfast Intervention: Low glycaemic load (LGL) breakfast consisting of a nut and seed granola with almond milk. The breakfast is to be consumed at a consistent time between 6:00am and 9:00am for seven consecutive mornings. A seven day food and exercise diary will be used to check adherence.
Post breakfast consumption, participants will be asked to follow current practice gestational diabetes mellitus diet prescription which consists of a moderate carbohydrate diet spread evenly across the da
Breakfast Intervention: Low glycaemic load (LGL) breakfast consisting of a nut and seed granola with almond milk. The breakfast is to be consumed at a consistent time between 6:00am and 9:00am for seven consecutive mornings. A seven day food and exercise diary will be used to check adherence. Post breakfast consumption, participants will be asked to follow current practice gestational diabetes mellitus diet prescription which consists of a moderate carbohydrate diet spread evenly across the day. Participants will also be advised on physical activity guidelines (RANZCOG). They should aim to achieve at least 30 minutes per day, five days per week of moderate intensity physical activity such as a brisk walk. There is also a 7 day wash out period between treatments where participants follow the current diet prescription and the physical activity guidelines.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* BMI:>18 kg/m2 * Diagnosed with gestational diabetes mellitus prior to 28 weeks’ gestation, based on the Australasian Diabetes in Pregnancy Society (ADIPS) criteria (fasting glucose more than or equal to 5.1 mmol/L, 1-h glucose more than or equal to 10.0 mmol/L and/or 2-h glucose more than or equal to 8.5 mmol/L following a 2-h 75g oral glucose tolerance test), * Singleton pregnancy * Intending to deliver at Royal Prince Alfred Hospital Women and Babies
Exclusion criteria
* Multiple pregnancy * Physical or psychological conditions that contraindicate participation including history of an eating disorder * Overt hypertriglyceridaemia (triglycerides > 5 mmol/L) * Current metformin or insulin therapy * Smoking * Current breastfeeding * Special dietary requirements (e.g. coeliac disease, veganism); nut allergy or lactose intolerance * Pre-existing diabetes or diabetes mellitus in pregnancy * Gestational diabetes mellitus diagnosed after 28 weeks’ gestation defined by ADIPS criteria.
Outcome results
None listed