Bariatric Surgery CandidateNCT05291741
Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
A study testing VLCD in people with Bariatric Surgery Candidate and Very Low Calorie Diet, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Very Low Calorie Diet, Weight Loss
- What is being tested?
- VLCD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for bariatric surgery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- VLCD, Standard care
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLCDDietary supplement
Advice regarding VLCD
Standard careDietary supplement
Standard dietary advice for weight loss before bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Very Low Calorie Diet (VLCD) | Active comparator | VLCD Receives: Dietary Supplement: VLCD |
| Standard care | Placebo comparator | Standard care Receives: Dietary Supplement: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 8 weeks
Secondary outcomes (5)
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
Measured: 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
In the questionnaire, the surgeon will be asked questions on details on the surgery, including duration of surgery and complicating factors.
Measured: 30 days after surgery
Use of health care services assessed by a medical chart review
We will assess the number of health care contacts for each patient.
Measured: 30 days after surgery
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.
Measured: 30 days after surgery
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291741
- Sponsor's protocol ID
- 1-16-02-436-21
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05291741
- Acronym / sponsor ID
- 1-16-02-436-21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very Low Calorie Diet (VLCD) | Active comparator | Dietary Supplement: VLCDVLCD |
| Standard care | Placebo comparator | Dietary Supplement: Standard careStandard care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for bariatric surgery
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLCDAdvice regarding VLCD | Dietary supplement | Very Low Calorie Diet (VLCD) |
| Standard careStandard dietary advice for weight loss before bariatric surgery | Dietary supplement | Standard care |
Primary outcome
Weight loss
Time frame: 8 weeks
5 secondary outcomes
Patient quality of life measured using the Short Form-12 (SF-12) questionnaire
Time frame: 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
Use of health care services assessed by a medical chart review
Time frame: 30 days after surgery
Severity of complications assessed by a medical chart review.
Time frame: 30 days after surgery
Presence of eating disorders
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLCD in people with Bariatric Surgery Candidate and Very Low Calorie Diet, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.