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PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery

NCT05918471 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-01-05

No results posted yet for this study

Summary

The PREPARE Pilot randomized controlled trial (RCT) is a multi-center, parallel, blinded RCT that aims to assess the feasibility of a full RCT comparing preoperative very low energy diets (VLEDs) to standard of care prior to elective non-bariatric surgery for obese patients in terms of overall 30-day postoperative morbidity. Adult patients with body mass indices (BMIs) greater than 30 kg/m2 will be randomized 1:1 to receive 3-weeks of preoperative VLED plus preoperative weight loss counselling or preoperative weight loss counselling alone. This trial will enroll patients to assess recruitment, compliance, and follow-up completion to assess the feasibility of a full RCT powered to assess for differences in 30-day postoperative between VLEDs and standard of care arms.

Conditions

  • Obesity
  • Non-Bariatric Surgery
  • Preoperative Weight Loss
  • Preoperative Optimization

Interventions

DIETARY_SUPPLEMENT

Very Low Energy Diet with Liquid Supplementation

The preoperative VLED protocol will utilize Optifast 900, a commercially available weight loss product sold by Nestlé Health Sciences. Optifast 900 is designed as a high-protein, low-carbohydrate, and low-fat meal replacement with complete micronutrient composition. Instructions for use are as follows: 1. Consume 4 Optifast 900 packets each day 2. Take 1 sachet of Optifast 900 once in the morning (AM), once at noon, once in the early evening (PM #1), and once later in the evening (PM #2) for three-weeks. 3. Mix 1 sachet with at least 300 mL (1 1⁄4 cups) of cold water. Shake well or blend in a blender.

Sponsors & Collaborators

Principal Investigators

  • Tyler J McKechnie, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-09-01
Completion
2024-10-31

Countries

  • Canada

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918471 on ClinicalTrials.gov