Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06461247 |
| Other study ID # |
2024/00240 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
May 2024 |
| Source |
National University Hospital, Singapore |
| Contact |
Melissa Tay Hui Juan |
| Phone |
67725166 |
| Email |
melissa_hj_tay[@]nuhs.edu.sg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The obesity rate in Singapore is rising, mirroring a similar worrying global trend. Bariatric
surgery has been the only long-term method proven to overcome severe obesity and it has
become an increasingly common and effective treatment option. Preoperative weight loss is
required to reduce cardiovascular risk, liver volume and decrease intra-abdominal fat. This
leads to enhanced surgical visibility and surgical access resulting in reduced intra- and
postoperative complications.
Currently, a ketosis-inducing programme, usually a liquid meal replacement, is the standard
of care for pre-operative dietary management. However, compliance with liquid meal
replacement is challenging primarily due to individual taste preferences, limited variety,
having to take a liquid diet, lifestyle factors, and other obstacles. It was found for taste
and gastrointestinal side effects to be the main issues.
Therefore, RTE meals are carefully formulated to provide the calculated calorie, controlled
net carbohydrate content, and are low in saturated and trans fat. By incorporating these
meals as a VLCD diet regime, it would allow patients to still enjoy the chewing sensation and
local favourites and flavours, while enjoying mealtime with their friends and families.
In this randomised controlled trial, patients listed for bariatric surgery from the NUH
Weight Management Clinic in Singapore will undergo randomization into either the Standard
Care or Intervention group during the baseline visit.
- Standard Care Group (n=60): Participants will be provided with liquid meal replacements
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.
- Intervention Group (n=60): Participants will be provided with the VLCD RTE meals for
lunch and dinner for 4 weeks and advised on a healthy keto breakfast.
All eligible participants (n=140) will be advised to keep within the 800 calorie limit and
50g net carbohydrate limit per day. They will receive guidance from a dietitian on lifestyle
changes and pre-bariatric surgery VLCD diets. Participants in both groups will also be
advised to download the nutritionist Buddy Keto app for monitoring of compliance, food
intake, steps count, weight progress and in app virtual reminders (automated and by
dietitians via the chat function).
