Lifestyle Changes, Mushroom Supplementation, and Bupropion to Reduce Adiposity and Cardiometabolic Risk

Korábbi kezelés

• Previous or planned bariatric surgery

Más betegség

• Present food intolerances and/or allergies of relevance to the interventions, such as celiac disease and allergy to edible mushrooms or fungal spores.
• Contraindication to bupropion, or any unacceptable risk with either treatment as assessed by the investigator. Specifically, and not covered elsewhere:
  • History of epilepsy or lowered seizure threshold;
  • History of bulimia or anorexia nervosa;
  • Central nervous system tumor;
  • Hypersensitivity to bupropion;
  • History of bipolar disorder;
  • Known or suspected Brugada syndrome;
• Any condition, as judged by the investigator, that suggests that the participant will be non-compliant or otherwise unsuitable to study medication or study participation. For example, serious psychiatric, eating, alcohol or substance abuse disorders.

Laborértékek

• Diagnosed diabetes, coronary heart disease, heart failure, stroke, liver failure or kidney disease (eGFR<60 ml/min/1.73m2) as well as other ongoing serious conditions with short life expectancy or conditions affecting participation in the study.
• Use of the following medications within indicated time frames:
  • Other bupropion-containing products (last 2 weeks);
  • Other weight lowering-drugs: orlistat, phentermine-topiramate, sodium-glucose transporter 2 inhibitors (SGLT2i), GLP-1 receptor agonists (last 3 months);
  • Antipsychotics, mirtazapine, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (last 3 months);
  • MAOIs (last 2 weeks);
  • Systemic glucocorticoids (last 3 months);
  • Testosterone, anabolic steroids (last 6 months);
  • Medications not listed above that are metabolized by CYP2D6;
  • Medications that affect CYP2B6;

Egyéb

• Current or recent adherence to a low-calorie diet, receipt of pharmacological treatment for weight loss, and/or weight loss of > 3 kg within the past 3 months.
• Be pregnant or intend to become pregnant during the study period.
• Involvement in the planning and/or conduct of the study.
• Ongoing participation in another interventional clinical trial.

• Men and women aged 18-55 years.
• BMI of 25.0 - 34.9 kg/m2.
• Signed informed consent.
• Have a mobile phone, tablet, or computer with internet access.
• Cardiometabolic risk factors: a) None of the following diagnoses: hypertension, hyperlipidemia, or prediabetes according to WHO classification (Stratum A); b) One or several of the following diagnoses: hypertension, hyperlipidemia, or prediabetes according to WHO classification (Stratum B).
• For women of childbearing potential: use of a highly effective birth control method