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

ConditionBariatric Surgery Candidate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Cognitive impairment.

Hypothyroidism

Chronic kidney disease

Hypothyroidism

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

  • Standard Care Group

    Other intervention

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Very Low Calorie Diet Ready-to-eat (VLCD RTE) mealsExperimental treatment 1 intervention
Group B: Liquid Meal ReplacementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Compliance rate of the RTE meals

The compliance rate is assessed via food logging in the nutritionist buddy keto app

Time frame
Daily for intervention period of 28 days
2

Blood Ketones Measurement

Fasting blood ketone measurements measured at study visit

Time frame
1st week, 2nd week, 3rd week, 4th week, surgery day

Secondary outcomes

1

Satisfaction of the RTE meals

Assessed via a self-reported questionnaire with a numeric scale of 1 to 5

Time frame
3rd week and surgery day
2

Weight Change

Weight changes at study visit

Time frame
1st week, 2nd week, 3rd week, 4th week, surgery day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Hospital, Singapore

Lead sponsor

Alexandra Hospital

Collaborator

Source ClinicalTrials.gov
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