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Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery

NCT06461247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-09-12

No results posted yet for this study

Summary

Currently, a ketosis-inducing programme, usually a liquid meal replacement, is the standard of care for pre-operative dietary management. However, compliance with liduiqd meal replacement is challenging primarily due to individual taste preferences, limited variety, having to take a liquid diet, lifestyle factors, and other obstacles. Therefore, there is a need for RTE meals to enhance patient satisfaction and compliance, ultimately resulting in improved pre-operative weight loss outcomes. Hence, this RCT study aims to determine whether Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals would lead to greater compliance as measured by blood ketones and meal logging via Nutritionist Buddy app (nBuddy App) compared to standard care liquid meal replacement (Optifast) prior to bariatric surgery.

Conditions

  • Bariatric Surgery Candidate

Interventions

OTHER

Very Low Calorie Diet Ready-to-eat (VLCD RTE) meals

Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy ketogenic breakfast. Participant will be expected to adhere to VLCD regimen containing 800 calories per day or fewer and keep within 50g net carbohydrates a day.

OTHER

Standard Care Group

Participants will be provided with liquid meal replacement for breakfast, lunch, and dinner for 4 weeks. Additionally, patients are to prepare 1 serving of non-starchy vegetables are to be included for lunch and dinner. Participant will be expected to adhere to VLCD regimen containing 800 calories per day or fewer and keep within 50g net carbohydrates a day.

Sponsors & Collaborators

  • Alexandra Hospital

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Melissa Tay · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Singapore

Study Locations

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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 NCT06461247 on ClinicalTrials.gov