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NCT07806279Not yet recruitingPhase 3

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

A 52-week Multicenter, Randomized, Parallel-group Trial in Overweight People Investigating Lifestyle Changes, Mushroom Supplementation and Bupropion to Reduce Adiposity and Cardiometabolic Risk

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
2 Sept 2026
Start date
30 Oct 2026
Primary completion date
31 Dec 2030
Lead sponsor
Uppsala University
NCT number
NCT07806279
EU CT number
2026-527136-13-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From 30 Oct 2026 to the primary completion date, 31 Dec 2030
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or planned bariatric surgery

Other illness

  • 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.

Lab values

  • 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;

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Region Uppsala
Coordinator of this site? Confirm its status
UppsalaSwedenNot yet recruiting
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenNot yet recruiting
Vaestra Goetalandsregionen
Coordinator of this site? Confirm its status
VaenersborgSwedenNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.