ObesityPreBarNCT02671279
Low Calorie Diet in Morbidly Obese Patients
A study testing Low calorie diet in people with Obesity, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2016to Dec 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 40-46 kg/m2
- The patients must not conduct a diet before admission.
- Fasting blood glucose <-7 nmol/l
Who cannot join
- Diabetes mellitus
- Treatment with antidiabetics
- Allergy for substances in the planned study-diet
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, Hordaland, 5020
Haugesund Sjukehus, Helse Fonna
Haugesund
About this study
Official title: Effect of 6 Days Low Calorie Diet Before Bariatric Surgery
This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.
Read the detailed description
The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.
At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.
During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.
This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.
- Conditions
- Obesity
- Being tested
- Low calorie diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low calorie dietDietary supplement
6 days of low calorie diet, estimated kcal 400-600/day.
| Study group | Role | What they receive |
|---|---|---|
| Low calorie diet | Other | Dietary intervention group Receives: Dietary Supplement: Low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet
Measured: 8 days
Secondary outcomes (1)
Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Haukeland 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna
- Responsible party
- Sponsor
- Investigators
- Gunnar Mellgren, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671279
- Sponsor's protocol ID
- 2015/361
- Acronym
- PreBar
- Status last verified
- Dec 2017
- First submitted
- 13 Jul 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bratveit M, Stromland PP, Laupsa-Borge J, Skumsnes L, Dagsland VH, Kvistad S, Vogt EC, McCann A, Thorsen HL, Diamantopoulos AP, Nedrebo BG, Mellgren G, Dankel SN. A Very-low-energy Fast Involves Increased Adipose Inflammatory Gene Expression: A 6-day Feeding Trial (FASTOMICS-6). J Clin Endocrinol Metab. 2026 Apr 22;111(5):1470-1483. doi: 10.1210/clinem/dgaf570.
PubMed 41150634
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6 Days Low Calorie Diet Before Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02671279
- Acronym / sponsor ID
- PreBar / 2015/361
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Fonna
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.
Detailed description
The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.
At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.
During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.
This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low calorie diet | Other | Dietary Supplement: Low calorie dietDietary intervention group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 40-46 kg/m2
- The patients must not conduct a diet before admission.
- Fasting blood glucose <-7 nmol/l
Key exclusion criteria (3 listed)
- Diabetes mellitus
- Treatment with antidiabetics
- Allergy for substances in the planned study-diet
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 |
|---|---|---|
| Low calorie diet6 days of low calorie diet, estimated kcal 400-600/day. | Dietary supplement | Low calorie diet |
Primary outcome
Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet
Time frame: 8 days
1 secondary outcome
Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet
Time frame: 8 days
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 13 Feb 2020.
- Derived from this study: PubMed 41150634Bratveit M, Stromland PP, Laupsa-Borge J, Skumsnes L, Dagsland VH, Kvistad S, Vogt EC, McCann A, Thorsen HL, Diamantopoulos AP, Nedrebo BG, Mellgren G, Dankel SN. A Very-low-energy Fast Involves Increased Adipose Inflammatory Gene Expression: A 6-day Feeding Trial (FASTOMICS-6). J Clin Endocrinol Metab. 2026 Apr 22;111(5):1470-1483. doi: 10.1210/clinem/dgaf570.
- 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.
Gunnar Mellgren, MD, PhD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low calorie diet in people with Obesity, run by Haukeland University Hospital at 2 sites in Norway.
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 3 inclusion and 3 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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. 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?
Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671279, which also lists 1 linked publication.
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 13 Feb 2020.