Cardiometabolic SyndromePhase 3NCT07806279
Lifestyle Changes, Mushroom Supplementation, and Bupropion to Reduce Adiposity and Cardiometabolic Risk
A Phase 3 study testing Bupropion 150 mg, Lyophilized powder from edible mushrooms and Lifestyle Management in people with Cardiometabolic Syndrome and Obesity and Cardiovascular Risk, run by Uppsala University at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cardiometabolic Syndrome, Obesity and Cardiovascular Risk, Overweight , Obesity
- What is being tested?
- Bupropion 150 mg, Lyophilized powder from edible mushrooms and Lifestyle Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesSweden
- Study dates
- 30 Oct 2026to 31 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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);
- 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;
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites
Vårdcentralen Närhälsan Dalaberg
Uddevalla
Mayada Badran, +46104416800, sheyda.sofizadeh@vgregion.se
Akademiskt Primärvårdscentrum, Samariterhemmets Vårdcentral
Uppsala
Mats Martinell, +46722051796, mats.martinell@uu.se
Uppsala University Hospital
Uppsala
Magnus Lundqvist, MD, PhD, +46 18 611 00 00, martin.lundqvist@medsci.uu.se
About this study
Official title: A 52-week Multicenter, Randomized, Parallel-group Trial in Overweight People Investigating Lifestyle Changes, Mushroom Supplementation and Bupropion to Reduce Adiposity and Cardiometabolic Risk
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.
Read the detailed description
This is a 12-month, multicenter, randomized, parallel-group, open-label, controlled trial investigating the effects of lifestyle changes, lyophilized powder from edible mushrooms, and bupropion treatment on adiposity and cardiometabolic risk in people with overweight. The study includes five parallel treatment arms: 1.Control; 2. Lifestyle; 3. Lifestyle + Dietary supplement; 4. Lifestyle + Pharmacological treatment; 5.Lifestyle + Dietary supplement + Pharmacological treatment.
250 subjects will be enrolled and randomized in five parallel groups with 50 subjects in each treatment arm. Randomization will be performed in four strata, defined by sex (male or female) and cardiometabolic risk factors (presence or absence of hypertension, hyperlipidemia, or prediabetes). The randomization for each stratum will be done within balanced blocks to ensure approximately equal numbers of subjects across the treatment arms within each stratum. The study population will be composed such that each level of the stratification factors is represented by at least 30% of participants, i.e., at least 30% men and 30% women, and at least 30% with and 30% without cardiometabolic risk factors.
Participants in treatment arm 4 and 5 receiving the pharmacological treatment will undergo re-randomization after 6 months (visit 4) in a 1:1 ratio to either discontinue the medication or continue at a maintenance dose.
The study comprises eight physical visits: enrolment visit (Visit 1), randomization visit (Visit 2), four follow-up visits conducted during the treatment period (Visit 3-6), and two follow-up visits conducted after the treatment period at 24 and 36 months after inclusion in the study (Visits 8, and 9). In addition, one follow-up assessment will be conducted via telephone 18 months after inclusion (Visit 7).
Long-term follow-up of the participants will be performed through national registers. Such data may be obtained for five years before and up to 20 years after inclusion in the study and will be assessed in relation to baseline data and data collected during the physical visits and telephone follow-up.
- Being tested
- Bupropion 150 mg, Lyophilized powder from edible mushrooms, Lifestyle Management
- Keywords
- Obesity Class I, Hypertension, Hyperlipidemia, Prediabetes
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Hypertension, Hyperlipidemias, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion 150 mgDrug
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 mushroomsDietary 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 ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care consisting of written lifestyle recommendations. |
| Lifestyle | Experimental | Personalized 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. Receives: Behavioral: Lifestyle Management |
| Lifestyle + Dietary Supplement | Experimental | Same lifestyle intervention as the Lifestyle treatment arm with an additional dietary supplement consisting of lyophilized powder of edible mushrooms. Receives: Dietary Supplement: Lyophilized powder from edible mushrooms; Behavioral: Lifestyle Management |
| Lifestyle + Pharmacological treatment | Experimental | Same 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. Receives: Drug: Bupropion 150 mg; Behavioral: Lifestyle Management |
| Lifestyle + Dietary Supplement + Pharmacological treatment | Experimental | Same 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. Receives: Drug: Bupropion 150 mg; Dietary Supplement: Lyophilized powder from edible mushrooms; Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Percent change in body weight.
Measured: 6 months after randomization
Secondary outcomes (2)
Clinically meaningful change in body weight
Proportion of participants achieving ≥5% reduction in body weight.
Measured: 6 months after randomization
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.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Lundqvist, MD, PhD, Principal investigator, Uppsala UniversityJan Eriksson, MD, PhD, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806279
- Sponsor's protocol ID
- IMPETUS-2026
- Other IDs
- 2026-527136-13-00
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.