FORMULITE versus traditional very low calorie diet (VLCD) for weight loss prior to Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity; Diet and Nutrition - Obesity; Non-alcoholic fatty liver disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001091493
• Lead Sponsor: Centre for Obesity Research and Education, Monash University

Brief Summary

INTRODUCTION: Very Low Energy Diets (VLED) improves surgical access during weight loss surgery by reducing liver volume. However, compliance rates with traditional VLED are variable, mainly due to gastrointestinal side effects. Formulite is a new formulation of VLED, with higher protein, soluble fibre and probiotics. These changes are theorised to improve GI side effects thus improving compliance. AIMS: To directly compare traditional VLED (Optifast) with the new high protein, fibre and probiotic VLED formulation (Formulite), and assess participants’ compliance, weight loss, side effects, and surgical access. METHODS: This was a randomised double-blinded study involving patients scheduled for weight loss surgery. We measured compliance, weight loss, satisfaction, side effects and ease of operating. RESULTS: There 35 participants in the Formulite group and 34 in the Optifast group. Urinary ketones at 2 weeks was higher in the Formulite group. Total body weight loss percentage and ease of surgery were not significant in both groups. Formulite produced less GI side effect compared to Optifast, however Optifast was ranked higher in terms of taste and satisfaction. CONCLUSIONS: This study suggested better ketosis, and therefore compliance, with the high protein high fibre formulation, with decreased GI side effects. However, this did not translate to better satisfaction, weight loss or surgeons’ perception of surgical access.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-12
• Study Completion: 2018-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Obese adult participants undergoing bariatric surgery

Exclusion Criteria

Unfit for bariatric surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with very low calorie diet (VLCD), as defined by: <br>- urinary ketones (to assess ketosis - Primary assessment)<br>- remaining VLCD after two weeks[Two weeks]

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms:<br>- e.g. abdominal bloating, nausea, diarrhoea, constipation. <br>A study diary will be kept during the 2 week trial. These will also be a questionnaire and interview at the end of the 2 week trial (Likert scale - previously validated) . [Two weeks];Patient quality of life (SF-36)[Two weeks];Liver size, as assessed by peri-operative MRI[Two weeks];Weight loss, assessed using digital scales[2 weeks];Acceptability of VLCD (Likert scale - validated)[2 weeks after starting VLCD (time of operation)]