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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

NCT05291741

Bariatric Surgery Candidate Very Low Calorie Diet Weight Loss

RECRUITING NA

Very Low Calorie Liquid Diet for Pre op Patients

NCT01748682

Morbid Obesity Steatosis

COMPLETED NA

Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks

NCT06649578

Bariatric Surgery Cost of Care Complications

COMPLETED

Randomized Trial of Preoperative Diets Before Bariatric Surgery

NCT01652105

Morbid Obesity Bariatric Surgery Gastric Bypass

UNKNOWN NA

Ketogenic Diet Prior to Bariatric Surgery

NCT06850493

Bariatric Surgery Candidate Ketogenic Dieting

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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=70): 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=70): 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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Standard Care Group (n=70): Participants will be having 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.

Intervention Group (n=70): Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy keto breakfast.

Both groups will be recommended to keep within the calorie limit to 800kcal and 50g net carbohydrates per day.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

It is not feasible to apply blinding to the study design due to the nature of the intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Participants (n=70) in the VLCD RTE meals group will be advised to follow a calorie-restricted healthy ketogenic diet , consuming a maximum of 800 calories and 50g net carbohydrate intake daily.

Participants will be provided with VLCD RTE meals for lunch and dinner for 4 weeks and advised on a healthy keto breakfast.

The participants will be expected to self-monitor their weight, physical activity and diet logs via the nutritionist buddy keto app. There will be in app virtual reminders (automated and by dietitians via the chat function) sent via the nutritionist buddy keto application for the 1 month for participants to log in their weight and meals.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Liquid Meal Replacement

Participants (n=70) in the liquid meal replacement group will be advised to follow very low-calorie diet, with a maximum of 800 calories and 50g net carbohydrate intake daily.

Participants will be provided with a 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.

The participants will be expected to self-monitor their weight, physical activity and diet logs via the nutritionist buddy keto app. There will be in app virtual reminders (automated and by dietitians via the chat function) sent via the nutritionist buddy keto application for the 1 month for participants to log in their weight and meals.

Group Type ACTIVE_COMPARATOR

Standard Care Group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 21 to 65 years old
* Scheduled for bariatric surgery at least 1 month prior
* BMI ≥ 27.5 kg/m2 (with type 2 diabetes mellitus or metabolic syndrome)
* Owns a smart phone with data plan
* English speaking

Exclusion Criteria

* Cognitive impairment.
* Hypothyroidism
* Chronic kidney disease
* Hypothyroidism
* Depression with ongoing psychology follow up
* Type 1 diabetes
* Liver Cirrhosis
* Pregnancy
* Heart Failure
* Active cancer or in remission for less than 5 years
* Vegetarian
* Observing the fast during the month of Ramadan
* Undergoing treatment with anti obesity medications (eg: Phentermine/Orlistat/Contrave/GLP-1 analogues etc)

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes