Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?

NCT07711548 | Not Yet Recruiting

• 1 other identifier: U1111-1326-4843
• Study Type: interventional
• Target: 292
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Semaglutide; Obesity; Overweight; Diet; Weight loss maintenance

Outcome Measures

Primary Outcomes (1)

• weight in kg

  body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)

Study Arms (2)

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

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

Behavioral: Rescue VLCD

Interventions

NutriAct plus BEHAVIORAL

Dietary pattern, vegetarian version of the NutriAct pattern

NutriAct plus

Rescue VLCD BEHAVIORAL

Very low calorie diet as full meal replacement over 28 days in case of weight regain

Rescue VLCD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• BMI ≥ 45 kg/m²
• intake of glucose lowering drugs
• presence of incretin-based treatment
• acute severe CVD
• uncontrolled hypertension
• severe hepatic or renal diseases
• severe food allergy or malabsorption disease
• active cancer
• condition after bariatric surgery
• history of eating disorder
• concurrent pregnancy and breastfeeding

Sponsors & Collaborators

• Knut Mai: lead
• 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
• Latvian Council of Science: collaborator
• Ministry of Health, Czech Republic: collaborator
• DLR Project Management Agency (DLR): collaborator
• Czech Health Research Agency: collaborator

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07