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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 ?
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Scientific title
Food as Medicine: Can nuts improve bowel health in people with end stage kidney disease without compromising biochemical parameters ?
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Secondary ID [1]
291756
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None
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Universal Trial Number (UTN)
U1111-1195-8698
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Failure
302980
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Condition category
Condition code
Renal and Urogenital
302446
302446
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
297869
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
301856
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% with bowel habit rated as 3 or 4 on the Bristol Stool chart
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Assessment method [1]
301856
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Timepoint [1]
301856
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weekly for 4 weeks post intervention commencement
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Primary outcome [2]
301857
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% with weekly predialysis serum potassium less than 6 mmol/L
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Assessment method [2]
301857
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Timepoint [2]
301857
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weekly for 4 weeks post intervention commencement
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Primary outcome [3]
301858
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% with weekly predialysis serum phosphate <1.8 mmol/L
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Assessment method [3]
301858
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Timepoint [3]
301858
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weekly for 4 weeks post intervention commencement
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Secondary outcome [1]
334120
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% with weekly predialysis serum CRP <5
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Assessment method [1]
334120
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Timepoint [1]
334120
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weekly for 4 weeks post intervention commencement
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Secondary outcome [2]
334121
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% 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.
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Assessment method [2]
334121
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Timepoint [2]
334121
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one month post intervention commencement
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Secondary outcome [3]
334122
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% 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.
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Assessment method [3]
334122
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Timepoint [3]
334122
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one month post intervention commencement
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Secondary outcome [4]
334123
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% 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.
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Assessment method [4]
334123
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Timepoint [4]
334123
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one month post intervention commencement
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Secondary outcome [5]
334124
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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.
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Assessment method [5]
334124
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Timepoint [5]
334124
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one month post intervention commencement
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Secondary outcome [6]
334126
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change in quality of life score (using the EQ-5D-5L assessment tool)
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Assessment method [6]
334126
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Timepoint [6]
334126
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one month post intervention commencement
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Secondary outcome [7]
334127
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change in symptom burden score using the POS-renal assessment tool
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Assessment method [7]
334127
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Timepoint [7]
334127
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weekly for 4 weeks post intervention commencement
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Secondary outcome [8]
334156
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change in cognitive assessment score using the MoCA cognitive screening tool
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Assessment method [8]
334156
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Timepoint [8]
334156
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one month post intervention commencement
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Secondary outcome [9]
339855
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Change in p cresyl sulphate as assessed by serum assay
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Assessment method [9]
339855
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Timepoint [9]
339855
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Weeks 0,4,10
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Secondary outcome [10]
339856
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Change in indoxyl sulphate as assessed by serum assay
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Assessment method [10]
339856
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Timepoint [10]
339856
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Weeks 0,4,10
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Eligibility
Key inclusion criteria
End stage kidney failure receiving satellite hemodialysis
not pregnant
not on acute antibiotics
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2017
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Actual
26/02/2018
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Date of last participant enrolment
Anticipated
31/01/2018
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Actual
28/02/2018
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Date of last data collection
Anticipated
31/10/2017
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Actual
15/05/2018
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Sample size
Target
45
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
7884
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
7885
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Shellharbour Hospital - Mount Warrigal
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Recruitment postcode(s) [1]
15838
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2500 - Wollongong
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Recruitment postcode(s) [2]
15839
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2528 - Mount Warrigal
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Funding & Sponsors
Funding source category [1]
296256
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Other
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Name [1]
296256
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Illawarra Health and Medical Research Institute
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Address [1]
296256
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University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country [1]
296256
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Australia
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Primary sponsor type
Government body
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Name
Illawarra Shoalhaven Local Health District
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Address
Wollongong Hospital, 252 Crown St, Wollongong, NSW 2500
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Country
Australia
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Secondary sponsor category [1]
295172
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University
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Name [1]
295172
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University of Wollongong
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Address [1]
295172
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University of Wollongong, building 41, room 309 , Northfields Ave, Wollongong, NSW 2522
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Country [1]
295172
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297493
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Joint Illawarra Shoalhaven Local Health District and Unversity of Wollongong Human Research Ethics Committee
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Ethics committee address [1]
297493
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University of Wollongong, Northfields Ave, Wollongong NSW 2522
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Ethics committee country [1]
297493
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Australia
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Date submitted for ethics approval [1]
297493
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16/05/2017
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Approval date [1]
297493
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19/09/2017
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Ethics approval number [1]
297493
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HREC/17/WGONG/93
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
74210
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Ms Kelly Lambert
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Address
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Wollongong hospital, Department of Clinical Nutrition, Level 5 Block C, Crown St, Wollongong, NSW, 2500
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Country
74210
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Australia
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Phone
74210
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+612 4221 4917
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Fax
74210
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Email
74210
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[email protected]
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Contact person for public queries
Name
74211
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Kelly Lambert
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Address
74211
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Level 5 Block C , Wollongong Hospital, Crown St, Wollongong, NSW 2500
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Country
74211
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Australia
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Phone
74211
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+612 4221 4917
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Fax
74211
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+61242534550
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Email
74211
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[email protected]
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Contact person for scientific queries
Name
74212
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Kelly Lambert
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Address
74212
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Level 5 Block C , Wollongong Hospital, Crown St, Wollongong, NSW 2500
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Country
74212
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Australia
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Phone
74212
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+612 4221 4917
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Fax
74212
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+61242534550
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Email
74212
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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