NCT06461247

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Sep 2026

First Submitted

Initial submission to the registry

June 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

June 5, 2024

Last Update Submit

September 5, 2025

Conditions

Bariatric Surgery Candidate

Keywords

Weight lossVery Low Calorie DietBody Weight

Outcome Measures

Primary Outcomes (2)

  • Compliance rate of the RTE meals

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

    Daily for intervention period of 28 days

  • Blood Ketones Measurement

    Fasting blood ketone measurements measured at study visit

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

Secondary Outcomes (2)

  • Satisfaction of the RTE meals

    3rd week and surgery day

  • Weight Change

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

Study Arms (2)

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

EXPERIMENTAL

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.

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

Liquid Meal Replacement

ACTIVE COMPARATOR

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.

Other: Standard Care Group

Interventions

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

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.

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

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.

Liquid Meal Replacement

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandra Hospital

Singapore, Singapore

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Weight LossBody Weight

Interventions

Meals

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Melissa Tay

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Tay Hui Juan

CONTACT

67725166melissa_hj_tay@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is not feasible to apply blinding to the study design due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 14, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will remain confidential and only accessible via lock and keys by the researchers.

Locations

SG(2)