About this trial
The goal of this clinical trial is to evaluate whether a 3-month dance-based exercise program combined with individualized nutrition can improve health outcomes in obese breast cancer survivors in remission. The main questions it aims to answer are:
Will the intervention reduce body weight, body fat, and visceral adiposity?
Will it improve cardiorespiratory fitness, motor performance, gut microbiota composition, and quality of life?
Researchers will compare women participating in the dance and nutrition program with a control group who maintain their usual lifestyle to see if the intervention leads to favorable metabolic, physical, and microbiome-related changes.
Participants will:
Attend supervised dance classes three times per week for 12 weeks.
Follow an individualized nutrition plan tailored to their resting metabolic rate.
Provide blood and stool samples, complete fitness tests, and answer quality-of-life questionnaires before and after the intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of breast cancer disease
At least one year after breast cancer treatment
Must be able to swallow tablets
Must be able to folow physical exercise training
Disqualifiers
Clinical diagnosis of Parkinson's disease
Insulin dependent diabetes
Infectious diseases within the past 2 months
Use of antibiotics within the past 4 weeks before recruitment
Trial design
Parallel
Treatments tested in this trial
Dance classes
Other interventionParticipants will attend supervised sessions three times per week, each lasting 60 minutes. Classes were instructed by certified professional dancers and incorporated structured choreographies from three dance genres: folkloric, Latin American, and contemporary.
Treatment groups
Trial outcomes
Primary outcomes
Gut Microbiota Composition (alpha and beta diversity indices)
Evaluated using 16S rRNA sequencing of fecal samples; primary indices include Shannon diversity, Chao1 richness, and Bray-Curtis dissimilarity
Metabolite outcome measures
Systemic inflammation and gut-related metabolites will be assessed by measuring blood biomarkers (hs-CRP, IL-6, TNF-α), fecal inflammatory markers (calprotectin, lactoferrin), and microbiota-derived metabolites including short-chain fatty acids (acetate, propionate, butyrate) in feces and plasma, as well as plasma metabolites such as TMAO and selected bile acids. Intestinal permeability will be evaluated through serum zonulin levels. Together, these measures will provide an integrated view of inflammatory status, microbial metabolic activity, and gut barrier function.
Quality of Life assesment
Change in Quality of Life (EORTC QLQ-C30 Global Health Score) measured using the EORTC QLQ-C30 questionnaire (version 3.0), with scores transformed to a 0-100 scale according to the scoring manual.
Secondary outcomes
Cardiorespiratory Fitness
Change in Cardiorespiratory Fitness (VO₂max, ml/min/kg) determined by incremental cardiopulmonary exercise testing on a cycle ergometer to evaluate aerobic capacity.
Body composition
Change in Fat Mass and Visceral Adiposity measured by bioimpedance (InBody 230 device) to assess reduction in total fat mass and visceral fat levels.
Sponsors and contacts
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