- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711548
Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity? (DIET-SLIM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: NutriAct plus
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
|
Dietary pattern, vegetarian version of the NutriAct pattern
|
|
Other: Rescue VLCD
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
|
Very low calorie diet as full meal replacement over 28 days in case of weight regain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight in kg
Time Frame: body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)
|
body weight in kg after weight loss (3 to 5 months) and dietary intervention (12 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1326-4843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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