NCT04433338

Brief Summary

Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting. This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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%
Sep 2020Jul 2027

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

June 12, 2020

Last Update Submit

January 2, 2025

Conditions

Bariatric SurgeryMorbid Obesity

Keywords

Bariatric surgeryMorbid ObesityWeight LossDietRYGB

Outcome Measures

Primary Outcomes (1)

  • Operative time of the RYGB procedure

    Duration of the surgical procedure, retrieved from the electronic medical record

    surgery

Secondary Outcomes (3)

  • Ease of the RYGB procedure

    surgery

  • Appearance of the patient's liver

    surgery

  • Post-operative weight loss

    4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery

Other Outcomes (4)

  • Feasibility of the diet

    During the 14-day intervention period

  • Compliance of the diet

    During the 14-day intervention period

  • Complication rate

    First 30 days post-surgery

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods. For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres. For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres.

Other: 14-day Low Calorie Diet

Control group

NO INTERVENTION

Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery.

Interventions

14-day Low Calorie DietOTHER

Participants will be asked to: * Use 4 (women) or 5 (men) Modifast meal replacements per day. * Daily consume a minimum of 250 grams of (raw) vegetables without dressing. * Daily consume 100 grams of lean meat/fish/meat analogues. * Daily consume two spoons of liquid oil * Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
  • Able to prepare the meal replacements at home

You may not qualify if:

  • Undergoing another bariatric procedure than primary RYGB.
  • Diabetes Mellitus
  • Contraindication for the usage of Modifast meal replacements:
  • Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds)
  • Veganism
  • Kidney failure (GFR \< 90 ml/min/1.73m2), liver failure or cardiac insufficiency
  • A heart attack (myocardial infarct) in the past twelve months
  • Cancer
  • Hypokalaemia: serum potassium level \<3.4 mmol/l
  • Phenylketonuria \& Porphyria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6811AD, Netherlands

Location

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric J Hazebroek, MD, PhD

    Vitalys, part of Rijnstate hospital/Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

September 29, 2020

Primary Completion

June 22, 2022

Study Completion (Estimated)

July 1, 2027

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)