Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

April 29, 2026 updated by: Aarhus University Hospital
To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Steno Diabetes Center Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible for bariatric surgery

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Very Low Calorie Diet (VLCD)
VLCD
Dietary supplement: VLCD
Advice regarding VLCD
Placebo Comparator: Standard care
Dietary supplement: Standard care
Standard dietary advice for weight loss before bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient quality of life measured using the Short Form-12 (SF-12) questionnaire
Time Frame: 8 weeks and 1 year
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
8 weeks and 1 year
Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose
Time Frame: 30 days after surgery
In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.
30 days after surgery
Use of health care services assessed by a medical chart review
Time Frame: 30 days after surgery
We will assess the number of health care contacts for each patient.
30 days after surgery
Severity of complications assessed by a medical chart review.
Time Frame: 30 days after surgery
We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.
30 days after surgery
Presence of eating disorders
Time Frame: At baseline
The patients will be asked to complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess whether diorderes eating is present. Scores range from 0 to 6 and a score of 4 and above indicate disordered eating.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-16-02-436-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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