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Is it safe for obese patients on dialysis to lose weight using Optifast?

Investigating the safety of a Low Calorie Diet using Optifast as a method of weight loss in obese patients receiving dialysis therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000218190
Enrollment
5
Registered
2019-02-14
Start date
2019-04-12
Completion date
2019-04-30
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Over a third (36%) of patients on dialysis at Northern Health (NH) are obese and are often advised to achieve a weight of < 100kg or BMI<30kg/m2 before being waitlisted for kidney transplantation. Low calorie diets aim for low daily energy consumption and evidence supports they can achieve significant weight loss results. However, there is limited evidence on whether the use of low calorie diets in dialysis patients is safe. The aim of this research is to undertake a quasi-experimental study to determine if using a low calorie diet incorporating Optifast meal replacement products is a safe method of weight loss for dialysis patients with obesity who need to lose weight for kidney transplantation eligibility. Participants will be prescribed a low calorie diet for 12 weeks and monitored closely by the multidisciplinary renal team to ensure patient safety.

Interventions

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 potassiu

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.

Sponsors

Nadia Obeid
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026