None listed
Conditions
Brief summary
Protocol: Kidney transplant recipients will be screened and enrolled at week 3 following transplantation. Participants will be randomised (1:1) to receive at 4 weeks post-transplant either inulin (intervention) or continue with standard care. Subjects randomised to receive inulin will be asked to drink 10g of inulin dissolved in 200ml water once daily for one week, and then twice daily for a further 3 weeks. Subjects randomised to standard care will be instructed to consume the same quantity of water, without additional supplementation. Compliance with fibre supplementation will be assessed by powder weight every 7 days. All participants will receive standard post-transplant care including immunosuppression and medication use will be recorded throughout the study. Participants will be asked to keep a 4-day food diary prior to and during the final 4 days of supplementation, to be analysed using Foodwerx. Subjects will undergo continuous glucose monitoring for 2 periods of 14 days, from week 3 and week 7 post-transplant, to measure insulin resistance (HOMA) and glycaemic control (mean glucose, time in diabetic range, GRADE and MAGE scores). Kidney function (eGFR, albuminuria) and allograft response (kidney biopsy and test for donor-specific antibodies) will be assessed at month 3 and at any time of graft dysfunction. Patients will provide blood and faecal samples for analysis of SCFA (serum and stool, by NMR spectroscopy) and microbiota/metagenome (stool, by 16s rRNA sequencing) at (1) pre-supplement; (2) last week of supplementation; (3) at month 3 post-transplant. Gut homeostasis (blood Zonulin, LPS, CRP, IL-6, IL-17) and symptoms (Gastrointestinal Ratings Scale), cardiovascular risk profile (lipids, blood pressure, weight, CVD events), infections and hospitalisations will be recorded.
Interventions
100% Inulin Powder (MYPROTEIN) Participants randomised to the intervention arm will be asked to supplement their diet with inulin for 4 weeks, commencing at day 28 post kidney transplant. Initially, participants will consume 10 grams of inulin in approximately 200mls of water each morning for one week, after which they will consume 10 grams morning and night for the remaining three weeks. Inulin will be provided as a powder in individual dose sachets (10 grams) and is readily soluble in water. Participants will be asked to return their fibre supplement sachets for measurement at each study visit. Participants will be asked to keep a 4-day food diary prior to and in the last 4 days of the fibre supplementation period. Study visits will consist of 1 x 1-hour visit per week to monitor adherence and safety during the intervention period.
Sponsors
Study design
Eligibility
Inclusion criteria
Recipients of a kidney transplant from a living or deceased donor, including patients who receive a kidney from an ABO blood group incompatible donor, or as part of the Paired Kidney Exchange Program Individuals aged >= 18 years old who are able to give informed consent, and a willingness to participate and comply with the study requirements
Exclusion criteria
Individuals diagnosed with significant gastro-intestinal diseases e.g. inflammatory bowel disease, coeliac disease Patients who receive anti-thymocyte globulin (ATG) as induction or treatment for rejection Acute rejection in the first 4 weeks post-transplant Delayed Graft Function requiring dialysis persisting beyond week 2 post-transplant Presence of gastrointestinal tract output stoma Current enrolment in another intervention or investigational drug trial Recipients of multi-organ transplants (dual or en-bloc kidney transplants are not excluded) Known food intolerance, allergy, or sensitivity to inulin or dietary fibre. The inability or the unwillingness of individual or legal guardian to give written informed consent