Clinical trial

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

Opening soon · Phase 3 · 1 countries · Registry ID NCT07806279

Opening soonPhase 3Interventional

What this study is about

The increasing prevalence of obesity, its serious health consequences, and the substantial economic burden on healthcare systems underscore a pressing need for effective, long-term prevention strategies that can be implemented in primary care. Emerging evidence suggests that combining lifestyle modification with dietary supplements and pharmacological treatment may enhance and prolong intervention effects, yet comparative long-term data on their individual and combined efficacy are limited. Therefore, this study aims to evaluate the independent and additional effects of a comprehensive lifestyle intervention, a mushroom-based dietary supplement, and bupropion treatment over 12 months, to identify more effective and sustainable strategies for obesity prevention in overweight and obese adults.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexAll

Healthy volunteersNot accepted

ConditionCardiometabolic Syndrome, Obesity and Cardiovascular Risk, Overweight , Obesity

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. History of epilepsy or lowered seizure threshold; 2. History of bulimia or anorexia nervosa; 3. Central nervous system tumor; 4. Hypersensitivity to bupropion; 5. History of bipolar disorder; 6. Known or suspected Brugada syndrome; * 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. * Previous or planned bariatric surgery * 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. * 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. * Use of the following medications within indicated time frames: 1. Other bupropion-containing products (last 2 weeks); 2. Other weight lowering-drugs: orlistat, phentermine-topiramate, sodium-glucose transporter 2 inhibitors (SGLT2i), GLP-1 receptor agonists (last 3 months); 3. Antipsychotics, mirtazapine, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (last 3 months); 4. MAOIs (last 2 weeks); 5. Systemic glucocorticoids (last 3 months); 6. Testosterone, anabolic steroids (last 6 months); 7. Medications not listed above that are metabolized by CYP2D6; 8. Medications that affect CYP2B6; * 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.

Treatments and study arms

Bupropion 150 mg

Drug

Bupropion sustained-release (SR) tablets will be administered for a total of either 6 or 12 months. Treatment will begin at 150 mg once daily for one week to optimize tolerability. If well tolerated, the dose will be increased to 150 mg twice daily (morning and early afternoon) as the target maintenance dose, until 6 months into the intervention period (visit 4). At visit 4, participants will be re-randomized to either discontinue the treatment, or continue at a maintenance dose of 150 mg daily, for the remainder of the intervention. Dose adjustments, temporary or, if necessary, permanent discontinuation will be permitted for participants experiencing adverse effects, including neuropsychiatric symptoms, insomnia, or clinically significant increases in blood pressure or heart rate

Lyophilized powder from edible mushrooms

Dietary Supplement

The lyophilized powder will consist of a mixture from two edible mushroom species: Hericium erinaceus and Pleurotus ostreatus. Participants randomized to the treatment arms receiving the lyophilized powder from edible mushrooms will be instructed to consume it as part of their daily diet. The lyophilized powder can be incorporated into an optional number of meals, at a weekly dose of 60 grams.

Lifestyle Management

Behavioral

The lifestyle intervention will be based on the healthy Nordic diet and increased physical activity. In addition, the intervention will include other behavioral changes related to health, such as stress management, better sleep, and mindfulness. Behavioral change support will be given through digital self-help content on a study-specific website as well as physical and digital group session.