Australian Clinical Trials

Broad Health Condition Renal and Urogenital
Diet and Nutrition

Specific Health ConditionKidney disease
Other diet and nutrition disorders

Trial FocusTreatment

Recruitment Details

Recruitment status
Completed

Recruitment State
NSW

Hospital
Wollongong Hospital - Wollongong

Postcode
2500 - Wollongong

Anticipated date of first participant enrolment6/05/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial summary

This trial aims to investigate the effects of a novel renal dietary intervention (rich in plant foods, utilising a whole food dietary approach) designed to improve diet quality, symptom burden, the gastrointestinal microbiome as well as other health outcomes in adults with moderate-severe, pre-dialysis chronic kidney disease. It is anticipated that this trial will improve overall diet quality by increasing the volume and variety of plant foods, improve quality of life and symptoms such as constipation, result in changes to the microbial community present in the gastrointestinal tract of participants and hence, observe a reduced production of gut microbiome derived metabolites/toxins which may include indoxyl sulfate and p-Cresyl sulfate

Key inclusion criteria

- Participants diagnosed with stage 3-4 CKD non-dialysing/ pre-dialysis (eGFR 15-59mL/min per 1.73m2) or individuals deemed suitable by the medical team (Nephrologist).
- Adults (aged 18 years old or more)
- Participants must be able to give informed consent; i.e. have no major cognitive or sensory impairment

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

•	Individuals who are less than 18 years of age
•	Individuals with intellectual or mental impairment as well as those with a hearing impairment will only be excluded if they cannot follow safety simple instructions due to concerns relevant to the safety of the patient. 
•	Individuals receiving dialysis
•	Individuals diagnosed with dysphagia and/or require texture modified diet
•	Any women who are found to be pregnant during the trial would need to be immediately excluded due to the increased medical demands of a pregnancy in kidney disease.
•	Individuals with past or present radiation to the bowel or large bowel resection
•	Individuals with advanced colorectal cancer
•	Individuals who consumed antibiotic therapy within 1 months of study commencement
•	Individuals with medically diagnosed irritable bowel syndrome, crohn’s disease or ulcerative colitis; 
•	Individuals who have had a clinically significant change to their immunosuppressant dose within the last 6 months (determined by the medical team) of study commencement.