Overweight (BMI > 25)SSRDNCT07372235
SSRD and Overweight
A study testing Dietary intervention with SSRD in combination with feedback information about the metabolic profile and Dietary intervention with SSRD without any feedback on metabolic profile in people with Overweight (BMI > 25), run by Region Skane.
Trial summary
The investigators have previously found that a starch- and sucrosereduced diet (SSRD) has led decreased gastrointestinal symptoms in patients with irritabel bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight (BMI > 25)
- What is being tested?
- Dietary intervention with SSRD in combination with feedback information about the metabolic profile and Dietary intervention with SSRD without any feedback on metabolic profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.
- BMI ≥25 kg/m2
Who cannot join
- Allvarlig födoämnesallergi
- Allvarlig hjärt, lung, kardiovaskulär, magtarm, malign eller psykisk sjukdom
- Pågående ätstörning
- Graviditet
- Står redan på en diet såsom vegan diet, regelbunden fasta >15 timmar per dag, eller låg kolhydrat hög fett (LCHF) diet de senaste 3 månaderna
- Alkohol och/eller drogberoende
- Stora ändringar i kroppsvikt de senaste 3 månaderna (≥3 kg)
- Står på viktreducerande läkemedel eller läkemedel som typ GLP-1 analoger
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Olle Melander, Professor contact
About this study
Official title: Comparison at Overweight Between Those Who Receive Feedback Concerning Their Metabolic Profile or Not During an Intervention With Modified Starch- and Sucrosereduced Diet (SSRD)
The investigators have previously found that a starch- and sucrosereduced diet (SSRD) has led decreased gastrointestinal symptoms in patients with irritabel bowel syndrome (IBS). At the same time, investigators found that the weight was reduced and the nutrient intake was improved with a more favorable metabolic profile. However, it is a challenge to change lifestyle, and most persons fail to keep on with an improved diet for a long time. Investigators therefore now want to conduct a clinical trial with SSRD in overweight/obesity for 3 months. Persons with a BMI >25 kg/m2 will be included. To examine whether a feedback about improved metabolic profile enhances the compliance, participants will be randomized to be informed or not about the metabolic profile after the 6-week visit. Investigator´s hypothesis is that information about the improvement in the metabolic profile should increase the motivation and compliance in the patients, and thereby render better effects.
Read the detailed description
Patients with overweight or obesity will be recrutied to this open-label, randomized clinical trial. All participants will be informed about the starch- and sucrosereduced diet (SSRD). The diet will be continued for 3 months, with a physical visit with completion of study questionnaires, blood and feces sampling and measurements of anthropometry at baseline, after 6 weeks and 3 months. Thereafter, participants are free to eat whatever they want, but will be examined again after 1 year. Participants will be randomized to whether participants should be informed or not about the metabolic profile measured at week 6. Participants who are randomized to get information about the metabolic profile, will be called when the blood samples have been analysed, and informed about the changes in metabolic and nutrient results between baseline and 6 weeks. The investigators will then evaluate whether participants who were randomized to get information about their blood samples after 6 weeks, will have better compliance to the diet, and thereby have better effect on weight reduction and metabolic profiles. At the blood sampling after 3 months, all participants will be informed about their metabolic profiles. It is also of interest to study the effect at follow-up after 1 year, to see whether participants who were informed at 6 weeks differ from participants who were not.
- Conditions
- Overweight (BMI > 25)
- Being tested
- Dietary intervention with SSRD in combination with feedback information about the metabolic profile, Dietary intervention with SSRD without any feedback on metabolic profile
- Keywords
- overweight, SSRD, metabolomics, feedback on dietary efficiency
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention with SSRD in combination with feedback information about the metabolic profileOther
All participants will recieve a dietary intervention. They will be informed at the 6-week control about the changes in metabolic profile since study start.
Dietary intervention with SSRD without any feedback on metabolic profileOther
All particpants will receive informaiton about the SSRD diet. However, the participants will not be informed about the metabolic profile at the 6-week control
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention without feedback | Active comparator | All participants in this arm will be recommended SSRD, but they do not receive any information about changes in their metabolic profiles after the 6-week control Receives: Other: Dietary intervention with SSRD without any feedback on metabolic profile |
| Dietary intervention with feedback | Active comparator | All participants in this arm will be recommended SSRD, and they receive information about changes in their metabolic profiles after the 6-week control Receives: Other: Dietary intervention with SSRD in combination with feedback information about the metabolic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean weight at 3 Months.
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where weight (kg) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in weight from baseline will be calculated. The main outcome is the weight change observed at 3 months.
Measured: 1 year
Change from Baseline in the Mean waist circumference at 3 Months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where waist circumferense (cm) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in waist circumference from baseline will be calculated. The main outcome is the change observed at 3 months.
Measured: 1 year
Change from Baseline in the body mass composition at 3 Months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, body mass composition is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in fat mass from baseline will be calculated. The main outcome is the change observed at 3 months.
Measured: 1 year
Secondary outcomes (10)
The change from baseline in the endocrine profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the endocrine profile. Half of the participants are randomized to receive feedback on the metabolic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in the endocrine profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the metabolic profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the metabolic profile. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in metabolic profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the epigenetic profile measured in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure epigenetics. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in epigenetic profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the nutrient profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the nutrient profile. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in nutrient profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the inflammatory profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year where blood samples are collected to analyse inflammatory parameters. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in inflammatory profile from baseline will be calculated, where the changes at 3 months will be the main outcome
Measured: 1 year
The change from baseline in the gut microbiota profile measured in feces at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where feces samples are collected. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in gut microbiota profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the quality of life at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where study questionnaires regarding quality of life are completed, and blood and feces samples are collected. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in quality of life (assessed by HAD, PHQ12-SS, and RAND-36) from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in bowel symptoms registered by VAS at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where study questionnaires regarding bowel symptmos are completed. Bowel symptoms are assessed on visual analog scales (VAS) from 0 mm (no symptoms) to 100 (max symptoms). Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in bowel symptoms from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the nutrient intake registered in digital diary food books at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year. Dietary registrations are performed digitally during 3 days at all time points for physical visits. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in nutrient intake according to the dietary registrations from baseline will be calculated, where the changes at 3 month will be the main outcome
Measured: 1 year
The change from baseline in the inflammatory profile in feces at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year where feces samples are collected to analyse inflammatory parameters. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in inflammatory profile from baseline will be calculated, where the changes at 3 months will be the main outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodil Ohlsson, Region Skane
- Investigators
- Cecilia Kennbäck, Registered Nurse, Study chair, Department of Internal Medicine, Skåne University Hospital, 20502 Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372235
- Sponsor's protocol ID
- 2025-07349-01
- Other IDs
- 2025
- Acronym
- SSRD
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical rules, it is not allowed to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison at Overweight Between Those Who Receive Feedback Concerning Their Metabolic Profile or Not During an Intervention With Modified Starch- and Sucrosereduced Diet (SSRD)
- ClinicalTrials.gov ID
- NCT07372235
- Acronym / sponsor ID
- SSRD / 2025-07349-01
- Conditions
- Overweight (BMI > 25)
- Keywords
- overweight, SSRD, metabolomics, feedback on dietary efficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 28 Jan 2026 (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.
The investigators have previously found that a starch- and sucrosereduced diet (SSRD) has led decreased gastrointestinal symptoms in patients with irritabel bowel syndrome (IBS). At the same time, investigators found that the weight was reduced and the nutrient intake was improved with a more favorable metabolic profile. However, it is a challenge to change lifestyle, and most persons fail to keep on with an improved diet for a long time. Investigators therefore now want to conduct a clinical trial with SSRD in overweight/obesity for 3 months. Persons with a BMI >25 kg/m2 will be included. To examine whether a feedback about improved metabolic profile enhances the compliance, participants will be randomized to be informed or not about the metabolic profile after the 6-week visit. Investigator´s hypothesis is that information about the improvement in the metabolic profile should increase the motivation and compliance in the patients, and thereby render better effects.
Detailed description
Patients with overweight or obesity will be recrutied to this open-label, randomized clinical trial. All participants will be informed about the starch- and sucrosereduced diet (SSRD). The diet will be continued for 3 months, with a physical visit with completion of study questionnaires, blood and feces sampling and measurements of anthropometry at baseline, after 6 weeks and 3 months. Thereafter, participants are free to eat whatever they want, but will be examined again after 1 year. Participants will be randomized to whether participants should be informed or not about the metabolic profile measured at week 6. Participants who are randomized to get information about the metabolic profile, will be called when the blood samples have been analysed, and informed about the changes in metabolic and nutrient results between baseline and 6 weeks. The investigators will then evaluate whether participants who were randomized to get information about their blood samples after 6 weeks, will have better compliance to the diet, and thereby have better effect on weight reduction and metabolic profiles. At the blood sampling after 3 months, all participants will be informed about their metabolic profiles. It is also of interest to study the effect at follow-up after 1 year, to see whether participants who were informed at 6 weeks differ from participants who were not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention without feedback | Active comparator | Other: Dietary intervention with SSRD without any feedback on metabolic profileAll participants in this arm will be recommended SSRD, but they do not receive any information about changes in their metabolic profiles after the 6-week control |
| Dietary intervention with feedback | Active comparator | Other: Dietary intervention with SSRD in combination with feedback information about the metabolic profileAll participants in this arm will be recommended SSRD, and they receive information about changes in their metabolic profiles after the 6-week control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.
- BMI ≥25 kg/m2
Key exclusion criteria (8 listed)
- Allvarlig födoämnesallergi
- Allvarlig hjärt, lung, kardiovaskulär, magtarm, malign eller psykisk sjukdom
- Pågående ätstörning
- Graviditet
- Står redan på en diet såsom vegan diet, regelbunden fasta >15 timmar per dag, eller låg kolhydrat hög fett (LCHF) diet de senaste 3 månaderna
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 |
|---|---|---|
| Dietary intervention with SSRD in combination with feedback information about the metabolic profileAll participants will recieve a dietary intervention. They will be informed at the 6-week control about the changes in metabolic profile since study start. | Other | Dietary intervention with feedback |
| Dietary intervention with SSRD without any feedback on metabolic profileAll particpants will receive informaiton about the SSRD diet. However, the participants will not be informed about the metabolic profile at the 6-week control | Other | Dietary intervention without feedback |
Primary outcome
Change from Baseline in the Mean weight at 3 Months.
Time frame: 1 year
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where weight (kg) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in weight from baseline will be calculated. The main outcome is the weight change observed at 3 months.
Change from Baseline in the Mean waist circumference at 3 Months
Time frame: 1 year
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where waist circumferense (cm) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in waist circumference from baseline will be calculated. The main outcome is the change observed at 3 months.
Change from Baseline in the body mass composition at 3 Months
Time frame: 1 year
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, body mass composition is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in fat mass from baseline will be calculated. The main outcome is the change observed at 3 months.
10 secondary outcomes
The change from baseline in the endocrine profile in blood at 3 months
Time frame: 1 year
The change from baseline in the metabolic profile in blood at 3 months
Time frame: 1 year
The change from baseline in the epigenetic profile measured in blood at 3 months
Time frame: 1 year
The change from baseline in the nutrient profile in blood at 3 months
Time frame: 1 year
The change from baseline in the inflammatory profile in blood at 3 months
Time frame: 1 year
The change from baseline in the gut microbiota profile measured in feces at 3 months
Time frame: 1 year
The change from baseline in the quality of life at 3 months
Time frame: 1 year
The change from baseline in bowel symptoms registered by VAS at 3 months
Time frame: 1 year
The change from baseline in the nutrient intake registered in digital diary food books at 3 months
Time frame: 1 year
The change from baseline in the inflammatory profile in feces at 3 months
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Due to ethical rules, it is not allowed to share individual participant data
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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.
Olle Melander, Professor contact
Cecilia Kennbäck, Registered Nurse study chair
Department of Internal Medicine, Skåne University Hospital, 20502 Malmö
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention with SSRD in combination with feedback information about the metabolic profile and Dietary intervention with SSRD without any feedback on metabolic profile in people with Overweight (BMI > 25), run by Region Skane.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bodil Ohlsson, Professor (+46 040 33 23 23, bodil.ohlsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean weight at 3 Months. (time frame: 1 year). The study lists 3 primary outcomes in all. 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 29 Apr 2026.