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Dietary Inulin for Gut Health in Solid-organ Transplantation (DIGEST)

An Investigator-Initiated, Randomized Controlled Trial Evaluating the Effect of High-Fibre Supplementation on Glycaemic Variability in Renal Transplant Recipients - A Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000623998
Acronym
DIGEST
Enrollment
40
Registered
2020-05-29
Start date
2020-06-05
Completion date
2021-02-01
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026