The goal of this randomized four-arm clinical trial is to determine the effect of 16-week water physical exercise program in thermal water and hydroponotherapy on lipide profile in middle-aged and elderly people, with controlled health conditions.
Participants will be randomizate into four arms:
* Arm I: Control * Arm II: Water Physical Exercise Program (WPEP) in thermal water * Arm III: Hydropinotherapy with thermal water combined with bay leaf (L. nobilis) * Arm IV: WPEP in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis)
Primary outcome:
1. Lipid profile (cholesterol total, low-density lipoprotein cholesterol (c-LDL), high-density lipoprotein cholesterol (c-HDL), triglycerides)
Secondary parameters: 2. Inflammatory biomarkers: interleukin-6 (IL-6), C-reactive protein (CRP) 3. Glucose metabolisc: fasting plasma glucose, insulin, Hemoglobin A1c (HbA1c) 4. Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, bilirubin, creatinine. 5. Anthropometric and clinical variables: weight, waist to hip ratio, body composition and bone mineral density 6. Systolic and diastolic blood pressure 7. Physical function 8. Lifestyle parameters: sleep quality, quality of life and eating habits
Men or women
Age: >45 years
Written informed consent prior to participation
Physical condition suitable for participating in physical exercise activities
Decompensated cardiovascular disease, renal insufficiency, or severe liver disease
Conditions preventing the ability in physical activity (e.g., severe respiratory issues, reduced mobility, severe arthritis)
Severe psychiatric or cognitive disorders that could affect comprehension or adherence to the study
Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or corticosteroids
Parallel
WPEP in thermal water
BehavioralWater Physical Exercise Program (WPEP) in thermal water The classes will take place in water maintained at 34°C. Training sessions will occur twice a week, with 50 minutes each and classes limited to 20 participants. Dumbbells and flotation devices will be used to increase exercise resistance, focusing on three main areas: upper body, lower body, and cardiorespiratory and abdominal exercises. Each session will begin with a 5-10-minute active warm-up period. The main workout will consist of a high-intensity interval training protocol with multi-joint exercises. The session will conclude with a 5-10-minute cool-down period. All sessions will be supervised and led by experienced exercise physiologists and physiotherapists to ensure participant safety and exercise efficacy.
Hydropinotherapy
Other interventionThe hydropinotherapy intervention consists of the oral ingestion of thermal water combined with bay leaf (Laurus nobilis). Participants assigned to this intervention will ingest 200 mL of Chaves thermal water infused with dried bay leaf (L. nobilis) twice per week. The infusion will be prepared by the research team by adding 5 g of dried bay leaf (L. nobilis) to the thermal water and allowing it to infuse for 15 minutes, followed by filtration through a strainer. All participants will be observed by the research team during ingestion to ensure compliance and safety. The thermal water used in this intervention is natural mineral water from Termas de Chaves, which emerges at a temperature of 77.0°C. It is classified as gasocarbonic, sodium bicarbonate, fluoride-based, and highly mineralized, with bicarbonate, chloride, sodium, and potassium as the predominant ions.
Lipid profile (total cholesterol, HDL-C, LDL-C, triglycerides)
Change in total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride concentrations (mg/dL), measured by enzymatic spectrophotometry, with LDL-C calculated.
Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) concentration (pg/mL), measured by enzyme-linked immunosorbent assay (ELISA)
C-reactive protein (CRP)
Change in serum C-reactive protein concentration (mg/L) measured by chemiluminescent microparticle immunoassay (CMIA).
Plasma Glucose
Change in fasting plasma glucose concentration (mg/dL), measured using standard laboratory methods.
Insulin
Change in fasting serum insulin concentration (µIU/mL), measured using standard laboratory methods.
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Instituto Politécnico de Bragança
Lead sponsor
Universidade do Porto
Collaborator
Universidade Federal do Paraná
Collaborator
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