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Improving Compliance with Very Low Energy Diets (VLEDs) Prior to Bariatric Surgery—a Randomised Controlled Trial of Two Formulations

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A Correction to this article was published on 01 July 2019

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Abstract

Introduction

Preoperative very low energy diets (VLEDs) improve access during bariatric surgery. Compliance with traditional VLED is variable, mainly due to gastrointestinal side effects. Formulite™ is a new formulation of VLED, with higher protein, soluble fibre and probiotics.

Aims

To compare traditional VLED (Optifast™) with the new VLED (Formulite™) and assess compliance, weight loss, satisfaction, side effects and surgical access.

Methods

This was a randomised double-blinded study involving patients scheduled for bariatric surgery. The primary outcome was compliance, assessed by urinary ketone concentration and proportion of patients in ketosis at 2 weeks. Secondary outcomes were weight loss, satisfaction and patient reported outcomes, gastrointestinal side effects and operative conditions.

Results

There were 69 participants: 35 in the Formulite™ group and 34 in the Optifast™ group. Ketosis at 2 weeks was achieved in both groups (88.5% vs 83.3%, Formulite™ vs. Optifast™, p = 0.602). Urinary ketones were higher with Formulite™ (1.5 vs 15 mmol/L, p = 0.030). Total body weight loss percentage, hunger and operative conditions were similar in both groups. Formulite™ produced less flatulence (score 3 vs 2, p = 0.010) and emotional eating (score 2 vs 1, p = 0.037); however, Optifast™ ranked higher in terms of taste (score 4 vs 3, p = 0.001) and overall satisfaction (score 5 vs 7, p = 0.011).

Conclusions

Compliance over 2 weeks was high in both VLEDs with most subjects achieving ketosis. Overall satisfaction was moderately high, although variable. Whilst Formulite™ is a viable alternative to Optifast™, better formulations of VLED that addresses key adverse effects, whilst achieving ketosis, would be of significant value.

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Change history

  • 01 July 2019

    In the original article the name of author Alexandra Klejn was misspelled.

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Wendy A. Brown.

Ethics declarations

Ethical Statement

Ethics approval was obtained from the Avenue Ethics Committee (ref no. 210). The trial was registered with the Australian Clinical Trials Register (ACTRN 12616001091493 at www.anzctr.org.au).

Consent Statement

All participants provided written informed consent.

Conflict of Interest

The product Formulite™ was donated by the manufacturer for the purpose of this study.

Author 1: no conflicts of interest to declare.

Author 2: no conflicts of interest to declare.

Author 3: no conflicts of interest to declare.

Author 4: no conflicts of interest to declare.

Author 5: no conflicts of interest to declare.

Author 6: received a grant from the NHMRC, outside the submitted work.

Author 7: received grants from Johnson and Johnson, grants from Medtronic, grants from GORE, personal fees from GORE, grants from Applied Medical, grants from Apollo Endosurgery, grants and personal fees from Novo Nordisc, personal fees from Merck Sharpe and Dohme, outside the submitted work.

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Davenport, L., Johari, Y., Klejn, A. et al. Improving Compliance with Very Low Energy Diets (VLEDs) Prior to Bariatric Surgery—a Randomised Controlled Trial of Two Formulations. OBES SURG 29, 2750–2757 (2019). https://doi.org/10.1007/s11695-019-03916-2

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  • DOI: https://doi.org/10.1007/s11695-019-03916-2

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