RecruitingNot ApplicableNCT06461247

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

Compliance With Standard Care vs Ready to Eat Meals Prior to Bariatric Surgery - a Randomised Controlled Trial


Sponsor

National University Hospital, Singapore

Enrollment

140 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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)

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Interventions

OTHERVery 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.

OTHERStandard 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.


Locations(2)

Alexandra Hospital

Singapore, Singapore

National University Hospital

Singapore, Singapore

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NCT06461247


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