None listed
Conditions
Brief summary
This is a 12-week double-blinded randomized control trial designed to assess the safety, feasibility and tolerability of a specialised dietary fibre supplement targeting the gut microbiota in children with type 1 diabetes (T1D); and to explore what impact it has on glycaemic control. Previous research has shown this dietary fibre supplement, which is a tapioca-based type-4 resistant starch that can be added to a normal diet, modifies the gut microbiota and promotes release of large amounts of the short chain fatty acids (SCFAs) after fermentation in the colon. In mice, the increase in SCFAs acetate and butyrate stopped pancreatic beta-cell damage providing near-complete protection from T1D. Studies in healthy human adults have shown this tapioca-based type 4 resistant starch supplement was well tolerated and improved glycaemic profiles through a reduction in post-prandial glucose and insulin excursions. In this study, children aged 5 – 14 years with T1D for at least 3 months, an HbA1c <9%, and BMI between 15th and 85th centile will be randomized to the intervention (tapioca-based type 4 resistant starch) or control (maize-based type 2 resistant starch) group. They will take this dietary fibre supplement daily for six weeks as part of their usual diet then return to their usual diet (without the dietary fibre supplement) for the final six weeks. They will be monitored throughout the study via in-person and phone reviews, with various measures including blood and stool samples, quality of life (QoL) questionnaires, supplement tolerability surveys, food diaries, continuous glucose monitoring (CGM), insulin dose reviews and growth parameters. The hypothesis is that inclusion of this tapioca-based type 4 resistant starch dietary fibre supplement into the normal diet of children with T1D will be safe, feasible and well tolerated; and it will also have a positive impact on their glycaemic control. It is hoped this study will provide important preliminary data for a Phase II study looking at efficacy of this supplement for preservation of beta-cell function and improving glucose homeostasis in children with newly diagnosed T1D.
Interventions
Tapioca-based type 4 resistant starch
- resistant starch and butyrate are the only active ingredients in this fibre supplement.
This is a colourless, tasteless, odourless powder that will be added to participants' usual diet for 6 weeks. It can be mixed with hot/cold food or drinks, dissolving easily without any effect on the starch structure. A dietitian will provide participants with information on how to incorporate the fibre supplement into their usual daily diet. The fibre supplement will b
Tapioca-based type 4 resistant starch - resistant starch and butyrate are the only active ingredients in this fibre supplement. This is a colourless, tasteless, odourless powder that will be added to participants' usual diet for 6 weeks. It can be mixed with hot/cold food or drinks, dissolving easily without any effect on the starch structure. A dietitian will provide participants with information on how to incorporate the fibre supplement into their usual daily diet. The fibre supplement will be transferred from its original packaging into blinded and coded containers each containing a sufficient amount of fibre supplement for one participant for 6 weeks. The labelling of these containers will be generic and not indicate the nature of the supplement. Dosing of the fibre supplement will be weight-based - participants < 25kg will take 10g/day (2 x 5g doses/day) - participants 25 - 50kg will take 20g/day (2 x 10g doses/day) - participants > 50kg will take 40g/day (2 x 20g doses/day) To improve tolerability, participants will start on 25% of the the total dose, increasing to 50%, 75% and then 100% (full dose) in two-day intervals. If a dose increase isn't tolerated, the participant will remain on the previous dose for two more days before trying to increase the dose again. If after three attempts the dose increase isn't tolerated, they will remain on the highest tolerated dose for the remainder of the 6 weeks. Participants will keep a log book of what doses of supplement they take each day during the 6 weeks and will be asked to return any leftover fibre supplement at the end of the 6 weeks. They will also have weekly phone reviews during the 6 weeks they are taking the fibre supplement to administer a supplement survey and monitor for issues.
Sponsors
Queensland Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
- Children and adolescents aged 5 – 14 years (inclusive) with T1D that was diagnosed at least 3 months prior to entry into the study - HbA1c less than or equal to 9% (75 mmol/mol) at the time of entry into the study - BMI between 15th centile and 85th centile, inclusive - The child/adolescent and their family are willing and able to follow the study protocol
Exclusion criteria
- Concomitant disease or treatment that may, in the judgement of the investigators, impact on glycaemic control, insulin requirements or other outcome measures - Hypoglycaemia unawareness - History or symptoms of malabsorption or gastrointestinal disease, including coeliac disease - Known liver or renal disease - On a restricted or special diet that would impact their ability to take the supplement e.g. intermittent fasting or ketogenic diet - Use of medication other than insulin that affects glucose homeostasis - Antibiotic usage within the six weeks prior to entry into the study or anticipated usage during the study
Outcome results
None listed