Obesity & OverweightDIET-SLIMNCT07711548
Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?
A study testing NutriAct plus and Rescue VLCD in people with Obesity & Overweight and Weight Loss Maintenance, run by Knut Mai.
Trial summary
So far, treatment with semaglutide (Wegovy) for therapy of obesity demonstrates substantial effects. However, most patients do not desire life-long pharmaceutical therapy or discontinue this treatment regime. This is accompanied by rapid weight regain. Moreover, numerous patients are open to an intermittent therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight, Weight Loss Maintenance
- What is being tested?
- NutriAct plus and Rescue VLCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Apr 2030
- 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
- BMI ≥ 30 kg/m² OR ≥ 27 kg/m² with concomitant cardiometabolic risk factors (metabolic syndrome, elevated blood pressure, dyslipidemia or impaired glucose metabolism (but not type 2 diabetes)
Who cannot join
- BMI ≥ 45 kg/m²
- intake of glucose lowering drugs
- presence of incretin-based treatment
- acute severe CVD
- uncontrolled hypertension
- severe hepatic or renal diseases
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- severe food allergy or malabsorption disease
- active cancer
- condition after bariatric surgery
- history of eating disorder
- concurrent pregnancy and breastfeeding
About this study
Official title: DIETary Strategies to stabiLize Incretin-based Weight Loss in Obesity Management
So far, treatment with semaglutide (Wegovy) for therapy of obesity demonstrates substantial effects. However, most patients do not desire life-long pharmaceutical therapy or discontinue this treatment regime. This is accompanied by rapid weight regain. Moreover, numerous patients are open to an intermittent therapy.
This trial aims to investigate whether two diet interventions can keep weight stable after weight loss with semaglutide in people with obesity or overweight.
- Conditions
- Obesity & Overweight, Weight Loss Maintenance
- Being tested
- NutriAct plus, Rescue VLCD
- Keywords
- Semaglutide, Obesity, Overweight, Diet, Weight loss maintenance
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriAct plusBehavioural
Dietary pattern, vegetarian version of the NutriAct pattern
Rescue VLCDBehavioural
Very low calorie diet as full meal replacement over 28 days in case of weight regain
| Study group | Role | What they receive |
|---|---|---|
| NutriAct plus | Other | Adults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will follow NutriAct plus for 12 months Receives: Behavioral: NutriAct plus |
| Rescue VLCD | Other | Adults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will receive rescue VLCD in case of weight regain for 12 months Receives: Behavioral: Rescue VLCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight in kg
Measured: body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startMar 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Knut Mai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Latvia, Institute for Clinical and Experimental Medicine, University of Vienna, ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN), Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke (DIfE), German Federal Ministry of Research, Technology, and Space (BMFTR), Austrian Science Fund (FWF), Czech Health Research Agency, Latvian Council of Science, Ministry of Health, Czech Republic, DLR Project Management Agency (DLR)
- Responsible party
- Sponsor-investigator, Knut Mai, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711548
- Sponsor's protocol ID
- U1111-1326-4843
- Acronym
- DIET-SLIM
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data Sharing Agreement still under negotiation
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIETary Strategies to stabiLize Incretin-based Weight Loss in Obesity Management
- ClinicalTrials.gov ID
- NCT07711548
- Acronym / sponsor ID
- DIET-SLIM / U1111-1326-4843
- Conditions
- Obesity & Overweight, Weight Loss Maintenance
- Keywords
- Semaglutide, Obesity, Overweight, Diet, Weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Knut MaiUniversity, hospital or other
- Collaborators
- University of Latvia, Institute for Clinical and Experimental Medicine, University of Vienna, ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN), Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke (DIfE), German Federal Ministry of Research, Technology, and Space (BMFTR), Austrian Science Fund (FWF), Czech Health Research Agency, Latvian Council of Science, Ministry of Health, Czech Republic, DLR Project Management Agency (DLR)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 17 Jul 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.
So far, treatment with semaglutide (Wegovy) for therapy of obesity demonstrates substantial effects. However, most patients do not desire life-long pharmaceutical therapy or discontinue this treatment regime. This is accompanied by rapid weight regain. Moreover, numerous patients are open to an intermittent therapy.
This trial aims to investigate whether two diet interventions can keep weight stable after weight loss with semaglutide in people with obesity or overweight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NutriAct plus | Other | Behavioral: NutriAct plusAdults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will follow NutriAct plus for 12 months |
| Rescue VLCD | Other | Behavioral: Rescue VLCDAdults with obesity who have lost >= 7% of their body weight with semaglutide therapy over 3-5 months and who will receive rescue VLCD in case of weight regain for 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 30 kg/m² OR ≥ 27 kg/m² with concomitant cardiometabolic risk factors (metabolic syndrome, elevated blood pressure, dyslipidemia or impaired glucose metabolism (but not type 2 diabetes)
Key exclusion criteria (11 listed)
- BMI ≥ 45 kg/m²
- intake of glucose lowering drugs
- presence of incretin-based treatment
- acute severe CVD
- uncontrolled hypertension
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 |
|---|---|---|
| NutriAct plusDietary pattern, vegetarian version of the NutriAct pattern | Behavioural | NutriAct plus |
| Rescue VLCDVery low calorie diet as full meal replacement over 28 days in case of weight regain | Behavioural | Rescue VLCD |
Primary outcome
weight in kg
Time frame: body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data Sharing Agreement still under negotiation
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NutriAct plus and Rescue VLCD in people with Obesity & Overweight and Weight Loss Maintenance, run by Knut Mai.
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 11 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 20 Jul 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?
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 in kg (time frame: body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)). 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 20 Jul 2026.