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

Overview

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.

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.