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
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