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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NutriAct plus
BehavioralDietary pattern, vegetarian version of the NutriAct pattern
Rescue VLCD
BehavioralVery low calorie diet as full meal replacement over 28 days in case of weight regain
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: NutriAct plusOther 1 intervention
Group B: Rescue VLCDOther 1 intervention
Trial outcomes
Primary outcomes
1
weight in kg
Time frame
body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options: