Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000600347
Ethics application status
Approved
Date submitted
23/04/2017
Date registered
27/04/2017
Date last updated
3/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Food as Medicine: Can nuts be used safely to improve bowel health in people with end stage kidney disease ?
Scientific title
Food as Medicine: Can nuts improve bowel health in people with end stage kidney disease without compromising biochemical parameters ?
Secondary ID [1] 291756 0
None
Universal Trial Number (UTN)
U1111-1195-8698
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Failure 302980 0
Condition category
Condition code
Renal and Urogenital 302446 302446 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the prescription of 40g of nuts (specifically raw almonds) daily for 4 weeks to individuals undertaking hemodialysis in a satellite hemodialysis unit in the Illawarra Shoalhaven Local Health District. Participants will undergo a 2 week washout period , then commence the intervention for 4 weeks. This will be followed by another 2 week washout period and 4 weeks of usual diet with no nuts.

Intervention adherence or fidelity will be assessed by a self recorded food diary and via the assessment of the remaining supply returned to the project coordinator each week
Intervention code [1] 297869 0
Treatment: Other
Comparator / control treatment
In this trial, patients will act as their own control (crossover study). The control period consists of 4 weeks of dietary intake as per usual dietary recommendations for people with kidney failure undertaking hemodialysis.

The usual recommendations for people undertaking hemodialysis are > 30kcal per kg; > 1.1g / kg of protein; <1000ml fluid per day; 1mmol/kg of potassium; < 100 mmol per day of sodium; > 30g fibre per day; < 1000mg of phosphate per day. Nuts are not recommended in the normal hemodialysis diet due to their high potassium and phosphate intake. The washout and control diet are the same recommendations as listed above ie the usual recommendations for people undertaking hemodialysis.
Control group
Active

Outcomes
Primary outcome [1] 301856 0
% with bowel habit rated as 3 or 4 on the Bristol Stool chart
Timepoint [1] 301856 0
weekly for 4 weeks post intervention commencement
Primary outcome [2] 301857 0
% with weekly predialysis serum potassium less than 6 mmol/L
Timepoint [2] 301857 0
weekly for 4 weeks post intervention commencement
Primary outcome [3] 301858 0
% with weekly predialysis serum phosphate <1.8 mmol/L
Timepoint [3] 301858 0
weekly for 4 weeks post intervention commencement
Secondary outcome [1] 334120 0
% with weekly predialysis serum CRP <5
Timepoint [1] 334120 0
weekly for 4 weeks post intervention commencement
Secondary outcome [2] 334121 0
% reaching dietary energy requirements of 125-146 kilojoules per kg ideal body weight as per evidence based guidelines (Ash et al, 2013). This will be assessed by a trained dietitian using a diet history and 24 hour recall approach.
Timepoint [2] 334121 0
one month post intervention commencement
Secondary outcome [3] 334122 0
% reaching dietary protein requirements of 1.1 g per kg ideal body weight as per evidence based guidelines (Ash et al, 2013). This will be assessed by a trained dietitian using a diet history and 24 hour recall approach.
Timepoint [3] 334122 0
one month post intervention commencement
Secondary outcome [4] 334123 0
% reaching dietary fibre targets of 30 g per day as per evidence based guidelines (Ash et al, 2013). This will be assessed by a trained dietitian using a diet history and 24 hour recall approach.
Timepoint [4] 334123 0
one month post intervention commencement
Secondary outcome [5] 334124 0
change in gut microflora profile (change in bacterial gut phyla and classes eg Actinobacteria, Bacteroidetes, Cyanobacteria, Firmicutes, Proteobacteria, and Verrucomicrobia) . This will be assessed using 16S ribosomal RNA gene
sequencing analysis from fecal samples.
Timepoint [5] 334124 0
one month post intervention commencement
Secondary outcome [6] 334126 0
change in quality of life score (using the EQ-5D-5L assessment tool)
Timepoint [6] 334126 0
one month post intervention commencement
Secondary outcome [7] 334127 0
change in symptom burden score using the POS-renal assessment tool
Timepoint [7] 334127 0
weekly for 4 weeks post intervention commencement
Secondary outcome [8] 334156 0
change in cognitive assessment score using the MoCA cognitive screening tool
Timepoint [8] 334156 0
one month post intervention commencement
Secondary outcome [9] 339855 0
Change in p cresyl sulphate as assessed by serum assay
Timepoint [9] 339855 0
Weeks 0,4,10
Secondary outcome [10] 339856 0
Change in indoxyl sulphate as assessed by serum assay
Timepoint [10] 339856 0
Weeks 0,4,10

Eligibility
Key inclusion criteria
End stage kidney failure receiving satellite hemodialysis
not pregnant
not on acute antibiotics
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy
receiving a short term course of antibiotics
allergy to almonds
dysphagia
dental problems
a current diagnosis of acute diverticulitits or fecal impaction
deemed unable to follow instructions adequately due to language or cognitive impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be collected in paper form and transferred to a study-specific database. Statistical analysis will be carried out using SPSS software (Version 22.0 for Windows, SPSS, Chicago, USA). Data normality for continuous variables will be assessed using the Shapiro Wilk test. Data will be reported as mean and standard deviations; median and interquartile range (IQR) or proportions as appropriate. All analyses will be conducted using the intention-to-treat (ITT) population corresponding to subjects having consumed at least 40g per day of almonds. Wilcoxon signed ranks, McNemar and paired sample t tests will be used where appropriate. Spearman’s correlation coefficient will used to assess the strength of association between variables such as fibre intake and frequency of bowel habit. Statistical significance will be set at P of less than 0.05. A trial sample size of n=34 was calculated using an effect size of 0.5 for the primary outcome with a power of 80% for detecting a ‘within group’ effect for the primary endpoint. An additional 30% was added to account for dropouts and incomplete data to reach a final sample size of n=45.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2017
Actual
26/02/2018
Date of last participant enrolment
Anticipated
31/01/2018
Actual
28/02/2018
Date of last data collection
Anticipated
31/10/2017
Actual
15/05/2018
Sample size
Target
45
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7884 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 7885 0
Shellharbour Hospital - Mount Warrigal
Recruitment postcode(s) [1] 15838 0
2500 - Wollongong
Recruitment postcode(s) [2] 15839 0
2528 - Mount Warrigal

Funding & Sponsors
Funding source category [1] 296256 0
Other
Name [1] 296256 0
Illawarra Health and Medical Research Institute
Country [1] 296256 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Wollongong Hospital, 252 Crown St, Wollongong, NSW 2500
Country
Australia
Secondary sponsor category [1] 295172 0
University
Name [1] 295172 0
University of Wollongong
Address [1] 295172 0
University of Wollongong, building 41, room 309 , Northfields Ave, Wollongong, NSW 2522
Country [1] 295172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297493 0
Joint Illawarra Shoalhaven Local Health District and Unversity of Wollongong Human Research Ethics Committee
Ethics committee address [1] 297493 0
University of Wollongong, Northfields Ave, Wollongong NSW 2522
Ethics committee country [1] 297493 0
Australia
Date submitted for ethics approval [1] 297493 0
16/05/2017
Approval date [1] 297493 0
19/09/2017
Ethics approval number [1] 297493 0
HREC/17/WGONG/93

Summary
Brief summary
Constipation is a common problem in people with end stage kidney failure. Treatment of this condition with a high fibre diet and adequate fluid is not possible in this group of people because they need to follow a specialized diet and restrict their fluid intake. The aim of this study is to determine if a non drug treatment in the form of 40g of almonds daily for 4 weeks will help improve the symptoms of constipation. Other outcomes such as improvements to the level of inflammation, dietary intake, memory, gut bacteria and quality of life will also be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74210 0
Ms Kelly Lambert
Address 74210 0
Wollongong hospital, Department of Clinical Nutrition, Level 5 Block C, Crown St, Wollongong, NSW, 2500
Country 74210 0
Australia
Phone 74210 0
+612 4221 4917
Fax 74210 0
Email 74210 0
klambert@uow.edu.au
Contact person for public queries
Name 74211 0
Kelly Lambert
Address 74211 0
Level 5 Block C , Wollongong Hospital, Crown St, Wollongong, NSW 2500
Country 74211 0
Australia
Phone 74211 0
+612 4221 4917
Fax 74211 0
+61242534550
Email 74211 0
klambert@uow.edu.au
Contact person for scientific queries
Name 74212 0
Kelly Lambert
Address 74212 0
Level 5 Block C , Wollongong Hospital, Crown St, Wollongong, NSW 2500
Country 74212 0
Australia
Phone 74212 0
+612 4221 4917
Fax 74212 0
+61242534550
Email 74212 0
klambert@uow.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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