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Very Low Calorie Diet in Patients Receiving Haemodialysis

Safety and Efficacy of Very Low Calorie Diet (VLCD) in Patients Receiving Haemodialysis Therapy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001351808
Enrollment
22
Registered
2021-10-07
Start date
2017-03-01
Completion date
2018-07-25
Last updated
2024-09-09

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

Conditions

None listed

Brief summary

The aim of this study is to determine if the use of a very low calorie diet (VLCD) with three meal replacement products per day is a safe and effective method for weight loss for patients with end stage renal failure undergoing haemodialysis (HD) therapy.

Interventions

Dietitian supervised very low calorie diet (VLCD) administered using meal replacement bars, shakes, soups and desserts (Optifast®, Nestle Health Science). Meal replacement products provided 600-800 calories per day. Patients will be provided with all meal replacements for the duration of the study. In addition to the meal replacement products patients were directed to consume 2 cups of low starch, low potassium vegetables plus 1 tsp oil per day. These were not supplied and patients were require

Dietitian supervised very low calorie diet (VLCD) administered using meal replacement bars, shakes, soups and desserts (Optifast®, Nestle Health Science). Meal replacement products provided 600-800 calories per day. Patients will be provided with all meal replacements for the duration of the study. In addition to the meal replacement products patients were directed to consume 2 cups of low starch, low potassium vegetables plus 1 tsp oil per day. These were not supplied and patients were required to purchase these themselves. Patients were assessed by renal dietitian weekly for the first four weeks and then fortnightly thereafter. One to one, face to face dietitian consultation and education including details regarding the individualised fluid restriction was performed. Dietitian consults were 30-60 minutes depending on number of questions and difficulties experienced by the patient. Duration of intervention 12 weeks. Adherence monitored via one to one interview and assessment of VLCD utilisation.

Sponsors

Department of Nephrology. Monash Medical Centre, Monash Health
Lead SponsorHospital

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 No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients >18 years on haemodialysis treatment either home or facility based. Body mass index (BMI) greater than 30kg/m2 . Able to give informed consent.

Exclusion criteria

Non-English speaking participants

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026