Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000218190
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
14/02/2019
Date last updated
16/04/2019
Date data sharing statement initially provided
14/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is it safe for obese patients on dialysis to lose weight using Optifast?
Scientific title
Investigating the safety of a Low Calorie Diet using Optifast as a method of weight loss in obese patients receiving dialysis therapy
Secondary ID [1] 296947 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 310897 0
Chronic Kidney Disease 310898 0
Condition category
Condition code
Diet and Nutrition 309568 309568 0 0
Obesity
Renal and Urogenital 309569 309569 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be prescribed a low calorie diet for 12 weeks using Optifast following the Optifast Very Low Calorie Diet Program, except the diet will be altered to meet the participant’s increased protein requirements (1.2g/kg/day) and fluid restrictions.
Participants will be required to consume each day:
• 3 of the Optifast products (shake, soup, dessert and/or bar)
• A serve of lean meat/fish/chicken if required to provide additional protein to meet requirements
• 2 cups of low potassium low starch vegetables
• One teaspoon oil
Participants will be reviewed by the Nephrologist at a minimum once every 4 weeks in clinic, and monitored by the dietitian and/or Chronic Kidney Disease (CKD) Coordinator (in clinic or the dialysis centre) to collect data weekly for the first two weeks, and then fortnightly for the remainder of the study, to monitor safety measures and assess progress including ideal body weight. Each assessment/data collection point will take approximately 20-30 minutes.
Reported compliance of the diet is recorded at each data collection point based on the participants self-reporting, and categorised in to one of the three following categories: daily compliance; alteration to prescribed diet (e.g. excluding one element); Non-compliance (e.g. eating non-prescribed food/drink). Participants who report altered or non-compliance will have follow with the renal dietitian (Principal Investigator) to discuss barriers to compliance.
Intervention code [1] 313378 0
Treatment: Other
Intervention code [2] 313573 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318716 0
1. Serious adverse events (SAEs) (to be recorded in aggregate and individually)
- Hypotension: defined by requirement to cease ultrafiltration or give fluid bolus on dialysis, MET call or Admission
- Hypoglycaemic episodes: documented Blood Glucose Level (BGL) <3.5mmol/L, OR symptomatic episode with any BGL requiring rescue therapy (glucose or glucose-rich foods, glucagon) in any setting, MET call or admission
- Hyperkalaemia
o Moderate to severe: any recorded potassium equal or greater than 6.0mmol/L (to be excluded if adjudicated to be artefactual)
o Severe: equal or great than 7.0mmol/L ,or equal or greater than 6.0mmol/L and symptomatic or with documented ECG changes
- Hyperphosphataemia: equal or greater than 3.0mmol/L and persistent > 4 weeks
- Ketoacidosis: Metabolic acidosis associated with serum ketones >1.5mmol/L and a HCO3 of <18mmol/L
- Other serious adverse events possibly related to intervention
Timepoint [1] 318716 0
Weeks 1, 2, 4, 6, 8, 10 and 12 after intervention commencement
Primary outcome [2] 318717 0
2. Study withdrawals
Timepoint [2] 318717 0
Week 12 after intervention commencement
Primary outcome [3] 318718 0
3. Change to body mass (weight) in kilograms
- Due to fluid based fluctuations in haemodialysis patients this will be prescribed ideal body weight (IBW)
Timepoint [3] 318718 0
Baseline, weeks 1, 2, 4, 6, 8, 10 and 12 (primary timepoint) after intervention commencement
Secondary outcome [1] 366843 0
Clinical Outcomes
- If on kidney transplantation waitlist as per documentation in the medical records
Timepoint [1] 366843 0
Week 12 after intervention commencement, and 6 months, 12 months after intervention completion
Secondary outcome [2] 366844 0
Clinical Outcomes
- If had a kidney transplant as per documentation in the medical records
Timepoint [2] 366844 0
Week 12 after intervention commencement, and 6 months, 12 months after intervention completion
Secondary outcome [3] 366845 0
Tolerability/ quality
- Per-protocol completion
Timepoint [3] 366845 0
Week 12 after intervention commencement
Secondary outcome [4] 366846 0
Tolerability/ quality
- Protocol breaches
Timepoint [4] 366846 0
Week 12 after intervention commencement
Secondary outcome [5] 366847 0
Tolerability/ quality
- Qualitative analysis of participant experience of the diet via semi structured interview
Timepoint [5] 366847 0
Week 12 after intervention commencement
Secondary outcome [6] 366848 0
Tolerability/ quality
- Continued use of low calorie diet as reported by participant
Timepoint [6] 366848 0
6 and 12 months after intervention completion
Secondary outcome [7] 366849 0
Changes in Anthropometry
- Changes in waist circumference in cm
Timepoint [7] 366849 0
Week 12 after intervention commencement
Secondary outcome [8] 366850 0
Changes in Anthropometry
- Changes in body composition analysis (including total body water, extracellular and intracellular water, lean tissue index, fat tissue index) using Body Composition Monitor
Timepoint [8] 366850 0
Week 12 after intervention commencement
Secondary outcome [9] 366864 0
Changes in cardiovascular risk profile
- Mean pre-dialysis blood pressure measured by systolic blood pressure
Timepoint [9] 366864 0
Week 12 after intervention commencement
Secondary outcome [10] 366865 0
Changes in cardiovascular risk profile
- HbA1c measured via blood test
Timepoint [10] 366865 0
Week 12 after intervention commencement
Secondary outcome [11] 366866 0
Changes in cardiovascular risk profile
- Lipid profile (total cholesterol, HDL, and LDL cholesterol and derived ratios; triglycerides) measured via blood test
Timepoint [11] 366866 0
Week 12 after intervention commencement
Secondary outcome [12] 366868 0
Changes in dialysis-associated parameters
- Dialysis prescription (Na, Ca, K, HCO3) as per documentation in the medical record
Timepoint [12] 366868 0
Weeks 1, 2, 4, 6, 8, 10 and 12 after intervention commencement
Secondary outcome [13] 366869 0
Changes in dialysis-associated parameters
- Biological targets (Pre-dialysis PTH, Ca++, PO4, Mg, TTR, K, Mg and Urea reduction ratio) measured via blood tests
Timepoint [13] 366869 0
Weeks 1, 2, 4, 6, 8, 10 and 12 after intervention commencement
Secondary outcome [14] 366870 0
Changes in selected biochemical nutritional- associated markers
- Serum albumin, ketones, acylated ghrelin, vitamin A
Timepoint [14] 366870 0
Weeks 1, 2, 4, 6, 8, 10 and 12 after intervention commencement
Secondary outcome [15] 366871 0
Resource allocation
- Dietitian visits based on number of contacts
Timepoint [15] 366871 0
Week 12 after intervention commencement
Secondary outcome [16] 366872 0
Resource allocation
- Non-protocol physician visits, emergency presentations and hospital admissions as per documentation in the medical records
Timepoint [16] 366872 0
Week 12 after intervention commencement

Eligibility
Key inclusion criteria
• BMI greater or equal to 30kg/m2
• Aged 18-65 years
• Receiving hemodialysis for a period of >3 months
• Documented by the NH or RMH nephrology team as ineligible for kidney transplantation due to obesity
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes:
• Subjective Global Assessment (SGA) score of B or C (moderately or severely malnourished)
• Severe cognitive impairment (as may not be able to follow safety instructions)
• Patients receiving peritoneal dialysis (as a significant amount of carbohydrate is absorbed from their dialysis fluid which contributes additional calories and may prevent ketosis)
• Type 1 Diabetes (more specialised care and monitoring including the Endocrinology department would need to be established for this group)
• Unstable Heart Failure, Ischaemic Heart Disease, Hepatic Disease, Porphyria (contraindication based on Optifast Clinical Treatment Protocol
• Taking Lithium, Digoxin, Warfarin or Anticonvulsants (risk of negative pharmacological interactions based on Optifast Clinical Treatment Protocol )
• Patients also ineligible for renal transplantation due to factors in addition to obesity (e.g. malignancy, uncontrolled infection, etc) that are likely to persist indefinitely

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A limit of 5 participants can be recruited given funding availability.
Data analysis: Data on safety and other outcomes will be summarised using descriptive statistics (medium [range]; count [percent]).
Qualitative data from semi-structured interviews will be analysed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
12/04/2019
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
5
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12938 0
The Northern Hospital - Epping
Recruitment hospital [2] 12939 0
Broadmeadows Health Service - Broadmeadows
Recruitment hospital [3] 12940 0
Craigieburn Health Service - Craigieburn
Recruitment postcode(s) [1] 25411 0
3076 - Epping
Recruitment postcode(s) [2] 25412 0
3047 - Broadmeadows
Recruitment postcode(s) [3] 25413 0
3064 - Craigieburn

Funding & Sponsors
Funding source category [1] 301515 0
Charities/Societies/Foundations
Name [1] 301515 0
Northern Health Foundation
Country [1] 301515 0
Australia
Primary sponsor type
Individual
Name
Nadia Obeid
Address
The Northern Hospital
Dietetics Department
185 Cooper Street
Epping Victoria 3076
Country
Australia
Secondary sponsor category [1] 301712 0
None
Name [1] 301712 0
N/A
Address [1] 301712 0
N/A
Country [1] 301712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302256 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302256 0
Ethics committee country [1] 302256 0
Australia
Date submitted for ethics approval [1] 302256 0
07/08/2018
Approval date [1] 302256 0
23/10/2018
Ethics approval number [1] 302256 0
HREC/44697/Austin - 2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89602 0
Mrs Nadia Obeid
Address 89602 0
The Northern Hospital
Dietetics Department
185 Cooper Street
Epping Victoria 3076
Country 89602 0
Australia
Phone 89602 0
+61 384052010
Fax 89602 0
Email 89602 0
[email protected]
Contact person for public queries
Name 89603 0
Nadia Obeid
Address 89603 0
The Northern Hospital
Dietetics Department
185 Cooper Street
Epping Victoria 3076
Country 89603 0
Australia
Phone 89603 0
+61 384052010
Fax 89603 0
Email 89603 0
[email protected]
Contact person for scientific queries
Name 89604 0
Nadia Obeid
Address 89604 0
The Northern Hospital
Dietetics Department
185 Cooper Street
Epping Victoria 3076
Country 89604 0
Australia
Phone 89604 0
+61 384052010
Fax 89604 0
Email 89604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified for use in publication/s and dissemination of results. No individual participant data will be shared or presented in such a way as to identify the participant.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.