Health TrialsbyHealthPanel

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

ConditionsCardiometabolic SyndromeObesity and Cardiovascular RiskOverweight , Obesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Present food intolerances and/or allergies of relevance to the interventions, such as celiac disease and allergy to edible mushrooms or fungal spores.

History of epilepsy or lowered seizure threshold;

History of bulimia or anorexia nervosa;

Central nervous system tumor;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: LifestyleExperimental treatment 1 intervention
Group C: Lifestyle + Dietary SupplementExperimental treatment 2 interventions
Group D: Lifestyle + Pharmacological treatmentExperimental treatment 2 interventions
Group E: Lifestyle + Dietary Supplement + Pharmacological treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in body weight

Percent change in body weight.

Time frame
6 months after randomization

Secondary outcomes

1

Clinically meaningful change in body weight

Proportion of participants achieving ≥5% reduction in body weight.

Time frame
6 months after randomization
2

Status of the composite of obesity and cardiometabolic risk conditions

Participants will be classified into ordered categories based on obesity status (body mass index \[BMI\] ≥30 kg/m² vs \<30 kg/m²) and number of cardiometabolic risk conditions (central adiposity, hypertension, hyperlipidemia, prediabetes/type 2 diabetes), forming a composite ordinal outcome analyzed using proportional odds models.

Time frame
6 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: