Does a high dietary intake of resistant starch affect glycaemic control and alter the gut microbiome in women with gestational diabetes? A randomised control trial protocol

Table 1 Participant measurements and collection summary

	Day 1	Day 3	Day 10	Day 28	Day 42	Day 56	Day 7 post-partum
Recruitment & consent	√
Randomisation of subjects	√
Attend clinic	√	√	√		√	√
Self-monitoring blood glucose data collection		√	√			√
FreeStyle Libre Pro application	√				√
Questionnaires:
medical Hx	√
medication	√
GI symptoms	√		√			√
Quality of Life SF36	√		√			√
Weight measured	√		√			√
3-day weighed food records collected		√	√			√
Bowel symptoms, RS supplement, medication & exercise diary collected		√	√			√
H₂ breath test		√	√			√
Fasting Bloods			√			√
Maternal stool samples		√	√			√	√
Neonatal stool sample							√
Maternal urine sample		√	√			√
Neonatal urine sample							√
Breastmilk sample							√
Study instructions and materials
RS diet education		√
supplement regime if applicable		√
Reminder phone call or text				√
Assessment of Medical Records for							√
adverse outcomes
delivery method
birth weight, length
feeding method
NICU admission
length of stay

ISSN: 1471-2393