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CompletedNCT05291741Updated May 5, 2026

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

An interventional study of VLCD and Standard care in Bariatric Surgery Candidate, Very Low Calorie Diet and Weight Loss, sponsored by Aarhus University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Read the 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.

02

Conditions studied

  • Bariatric Surgery Candidate
  • Very Low Calorie Diet
  • Weight Loss

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03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 85 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible for bariatric surgery

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
85 participants (actual)

Study arms

  • Active comparator
    Very Low Calorie Diet (VLCD)

    VLCD

    Dietary Supplement: VLCD

  • Placebo comparator
    Standard care

    Standard care

    Dietary Supplement: Standard care

Interventions

  • Dietary supplementVLCD

    Advice regarding VLCD

  • Dietary supplementStandard care

    Standard dietary advice for weight loss before bariatric surgery

06

What researchers measure

Primary outcomes

  1. Weight loss

    Time frame: 8 weeks

Secondary outcomes

  1. Patient quality of life measured using the Short Form-12 (SF-12) questionnaire

    Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

    Time frame: 8 weeks and 1 year

  2. Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose

    In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.

    Time frame: 30 days after surgery

  3. Use of health care services assessed by a medical chart review

    We will assess the number of health care contacts for each patient.

    Time frame: 30 days after surgery

  4. Severity of complications assessed by a medical chart review.

    We will define the severity of the contacts based on whether they are outpatient or inpatient contacts.

    Time frame: 30 days after surgery

  5. Presence of eating disorders

    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.

    Time frame: At baseline

07

Study locations

1 site
  • Steno Diabetes Center Aarhus
    Aarhus, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05291741
Lead sponsor
Aarhus University Hospital
Responsible party
Sponsor
First posted
Mar 23, 2022
Start date
Oct 1, 2022
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024
Last update
May 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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