Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKnut Mai
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
BMI ≥ 45 kg/m²
intake of glucose lowering drugs
presence of incretin-based treatment
acute severe CVD
Trial design
Treatments tested in this trial
- NutriAct plus
- Rescue VLCD
Treatment groups
292 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Knut Mai
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution
University of Latvia
Collaborator
Institute for Clinical and Experimental Medicine
Collaborator
University of Vienna
Collaborator
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)
Collaborator
Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke (DIfE)
Collaborator
German Federal Ministry of Research, Technology, and Space (BMFTR)
Collaborator
Austrian Science Fund (FWF)
Collaborator
Czech Health Research Council
Collaborator
Latvian Council of Science
Collaborator
Ministry of Health, Czech Republic
Collaborator
DLR Project Management Agency (DLR)
Collaborator
Source ClinicalTrials.gov