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
2 other identifiers
interventional
250
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2026
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2026
CompletedFirst Posted
Study publicly available on registry
September 8, 2026
CompletedStudy Start
First participant enrolled
October 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
Study Completion
Last participant's last visit for all outcomes
December 31, 2030
September 8, 2026
September 1, 2026
4.2 years
September 2, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Percent change in body weight.
6 months after randomization
Secondary Outcomes (2)
Clinically meaningful change in body weight
6 months after randomization
Status of the composite of obesity and cardiometabolic risk conditions
6 months after randomization
Study Arms (5)
Control
NO INTERVENTIONStandard care consisting of written lifestyle recommendations.
Lifestyle
EXPERIMENTALPersonalized lifestyle intervention, including but not limited to the heathy Nordic diet, increased physical activity, stress and sleep management, access to a study-specific website, and a flexible support system.
Lifestyle + Dietary Supplement
EXPERIMENTALSame lifestyle intervention as the Lifestyle treatment arm with an additional dietary supplement consisting of lyophilized powder of edible mushrooms.
Lifestyle + Pharmacological treatment
EXPERIMENTALSame lifestyle intervention as the Lifestyle treatment arm with an additional treatment of bupropion during the first 6 months of the intervention. At 6 months, participants in this treatment arm will be further randomized to either discontinue bupropion or continue bupropion at a lower maintenance dose.
Lifestyle + Dietary Supplement + Pharmacological treatment
EXPERIMENTALSame lifestyle intervention as the Lifestyle treatment arm with an additional dietary supplement consisting of lyophilized powder of edible mushrooms and treatment of bupropion. At 6 months, participants in this treatment arm will be further randomized to either discontinue bupropion or continue bupropion at a lower maintenance dose. The dietary supplement will be continued unchanged for the full 12 month treatment period.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- 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:
- 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);
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Vårdcentralen Närhälsan Dalaberg
Uddevalla, Sweden
Akademiskt Primärvårdscentrum, Samariterhemmets Vårdcentral
Uppsala, Sweden
Uppsala University Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Lundqvist, MD, PhD
Uppsala University
- STUDY CHAIR
Jan Eriksson, MD, PhD
Uppsala University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2026
First Posted
September 8, 2026
Study Start (Estimated)
October 30, 2026
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
September 8, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
De-identified individual participant data that underlie the results, together with a data dictionary, will be made available to researchers whose proposed use has been approved by the IMPETUS scientific steering committee. Data will be available from 12 months after publication for 5 years. Proposals should be directed to the principal investigator; requesters will be asked to sign a data access agreement, and access will be provided within a secure analysis environment in Sweden, since transfer of individual-level data outside the approved environment is restricted by the ethics approval and by national legislation.