70
Participants
Start Date
April 14, 2025
Primary Completion Date
July 31, 2026
Study Completion Date
March 31, 2027
early time restricted Mediterranean diet
Participants will start with a calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) for a period of six months. Participants are asked to stop eating at 6PM. This results in a daily fasting window of approximately 14 hours. A daily caloric intake of 500 kcal compared to the calculated energy requirement is assumed to stimulate weight loss.
Mysimba
Participants will take Mysimba twice daily at a total dose of 32 mg/360 mg naltrexone/bupropion per day for a duration of six months. The dosage will be built up in the first month following the stepped care approach used in the SmPC. Participants receive usual care, including the advice of 60 minutes of exercise per day and standard dietary recommendations according to the guidelines for the Dutch population.
RECRUITING
Franciscus, Rotterdam
Carmen Dietvorst
OTHER