None listed
Conditions
Brief summary
Previous studies have shown specialized dietary fibre supplements can prevent type 1 diabetes in mice by altering the gut bacteria, reducing inflammation around the body and preventing the autoimmune destruction of the insulin-producing cells in the pancreas. While this fibre supplement has been used to treat other health conditions in humans, it has yet to be determined whether humans with type 1 diabetes will experience the same protection as mice. This pilot research trial therefore aims to determine whether a large clinical trial of this fibre supplement that releases high concentrations of the natural products, acetate and butyrate, is a) feasible, b) safe and c) well-tolerated in adults with established type 1 diabetes, and to (d) determine whether this supplement affects any markers of diabetes, such as changes in the gut microbiota and inflammatory markers, which would indicate the supplement would have a similar effect on type 1 diabetes protection in humans as in mice. To achieve these aims, we will conduct a pilot study in 25 adults with pre-existing type 1 diabetes consuming the dietary fibre supplement twice daily for 6 weeks, with a follow-up at 12 weeks. The supplement is an ordourless, tasteless powder that dissolves easily in cold or hot foods. Eligible participants will attend the study centre on 4 separate occasions (baseline, 3, 6 and 12 weeks) and will receive dietary counselling and an individualised plan for the times of day they take the supplement and the specific foods in their usual diet they incorporate it into. Participants will be monitored closely for changes in their blood, urine and stool pathology, their blood glucose control, insulin requirements, and any side effects or feedback on the supplement. Blood and stool samples will also be taken to at each visit to assess the preliminary efficacy of the dietary supplement and ensure the laboratory experiments are feasible for a future large clinical trial.
Interventions
This trial is a single arm, safety, tolerability and feasibility trial of a fibre supplement in adults with type 1 diabetes. The supplement is a high-amylose maize starch modified by acetylation and butyrylation. The supplement will be administered to adult participants at a dose of 40g/day for 6 weeks. The dose will be divided in two daily 20g doses, taken at a similar time each day, and combined with warmed or cold food of their choice (e.g. sauces, soups, yoghurt).
To improve tolerability, p
This trial is a single arm, safety, tolerability and feasibility trial of a fibre supplement in adults with type 1 diabetes. The supplement is a high-amylose maize starch modified by acetylation and butyrylation. The supplement will be administered to adult participants at a dose of 40g/day for 6 weeks. The dose will be divided in two daily 20g doses, taken at a similar time each day, and combined with warmed or cold food of their choice (e.g. sauces, soups, yoghurt). To improve tolerability, participants will start at 25% of the total dose (i.e. 10g/day) and increase the dose in 10g increments every 2 days. If the increased dose is not tolerated, the participant will remain on the previous dose for an additional 2 days before attempting the increased dose again. If that dose is not tolerated after the third attempt, they will remain on the previous dose for the remainder of the intervention. Adherence to the intervention will be assessed through the supplement dose logbook and supplements returned in the following visit.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• 18 to 45 years, males and females • Clinical diagnosis of T1D for at least 6 months • HbA1c less than or equal to 8.5% • Willing and able to follow study protocol • stable disease management
Exclusion criteria
Current or planned pregnancy or lactation during the study • Use of diabetes medications other than insulin that affect glucose homeostasis • Hypoglycaemia unawareness • Concomitant disease or treatment that may, in the judgment of the investigators, impact on glycaemic control, insulin requirements or other outcome measures • History or symptoms of gastrointestinal disease or malabsorption, including coeliac disease • Any known condition that could be associated with poor compliance (e.g. drug/alcohol abuse) • Weight below 50kg and above 120kg (to ensure full dose between 0.33- 0.80g/kg/day) • Known liver or renal disease • Use of senor-augmented insulin therapy (i.e. Medtronic 640G pump with low glucose suspend) • Unwillingness to maintain their normal stable diet during the study and/or following a restrictive diet that would impact their ability to take the supplement (e.g. intermittent fasting). • Recent antibiotic usage (previous 6 weeks) or anticipated antibiotic usage during the study.
Outcome results
None listed