None listed
Conditions
Brief summary
The study will investigate whether a diet high in foods rich in Resistant Starch (RS), with or without the addition of a RS supplement, changes the gut microbial composition and blood glucose control compared with usual dietary advice (control) in women with newly diagnosed Gestational Diabetes (GDM). Data will be collected at Baseline, Day 7 of intervention, and 36-weeks of gestation and include dietary RS consumption, stool microbial analysis and short chain fatty acid content, fasting and post-meal blood glucose levels, time in optimal glycaemic range, the requirement for glucose-lowering medication, maternal and neonatal health outcomes, and health care costs. We hypothesise that, compared with standard GDM dietary advice, women with a high dietary intake of RS beginning at the diagnosis of GDM will show a reduction in fasting blood glucose levels and other measures of blood glucose control.
Interventions
Resistant Starch (RS) Dietary Intervention Women who are randomised to either of the two dietary intervention groups (RS Diet or RS Supp). Both groups will receive dietary education on consuming a high RS diet from whole foods. All RS dietary education will be conducted face-to-face at Fiona Stanley Hospital by the Principal Investigator, who is a Dietitian with over 30 years experience. The education will be conducted during a single 30 minute individual session. A standardised teaching plan will be used and participants will be provided with written nutrition education material and sample menus specifically developed for this study. They will also receive a "Gut Feeling" cookbook which was written by researchers at Edith Cowan University and is available for purchase from www.ecu.edu.au/schools/medical-and-health-sciences/our-research/systems-and-intervention-research-centre-for-health/news-and-events/sirch/2017/07/gut-feeling-mindful-menus-for-the-microbiome The RS education tools and strategies have been piloted by this group in a non-pregnant population and achieved a median increase in dietary RS intake of greater than 6.6 g RS per day. The high RS diet will commence on Day 3 of the trial and continue until delivery of the baby. RS Supplement (RS Supp) In addition to a high RS diet, the RS Supp group will be instructed to begin to consume a powdered RS supplement of high-amylose maize type 2 resistant starch (HAMS-RS2). The supplement will be stirred into cold foods such as yoghurt, smoothies, mashed banana and hummus. Participants will introduce HAMS over a two-day adjustment period by consuming 20 g per day, half a sachet morning and night for two days. Then, increasing to a split dose of 2 x 20 g per day for the remainder of their pregnancy. The RS supplement contains 60 percent RS type 2. The final amount of RS in the 40 g of HAMS per day will be 24 g. Participants will have face-to-face or telephone contact with the Chief Investigator approximately every 2 weeks to assess adherence to the diet and supplement (if applicable), to remind them of the next steps in the study protocol and to answer questions. The last contact with the participants will be at 1-week post-partum. Adherence to the dietary and supplement interventions will be monitored via 3-day food diaries (Baseline to Day 3, Days 7-9 and three consecutive days in the 35th week of gestation), RS supplement consumption records, measurement of change in gut microbiota and increase in stool short chain fatty acid content.
Sponsors
Study design
Eligibility
Inclusion criteria
Diagnosed with GDM by a 75 g Oral Glucose Tolerance Test (OGTT) between 24-30 weeks of pregnancy and greater than or equal to 18 years of age. A diagnosis of GDM is made using the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria of one or more values reaching the following levels – Fasting glucose of greater than or equal to 5.1 mmol/L, 1-hour of greater than or equal to 10.0 mmol/L, 2-hours of greater than or equal to 8.5 mmol/L.
Exclusion criteria
Early diagnosis of GDM before 24 weeks; Overt Diabetes in Pregnancy; Type 1 Diabetes; T2DM; poorly controlled hypothyroidism; Graves’ Disease; twin pregnancy; breastfeeding; vegetarian; vegan; irritable bowel syndrome; inflammatory bowel disease; previous bariatric surgery; history of an eating disorder; antibiotic use in the past 3 months; use of steroids, antipsychotics, metformin, laxatives, fibre supplements or probiotic supplement; allergy to adhesives; any major medical disorder; any psychosocial issues likely to impact on ability to adhere to study protocol.