Effects of a 4-month Intervention on Cardiometabolic, Hormonal, Inflammatory, Liver, Renal, Electrolyte, and Muscle Enzyme Parameters in Pre- and Post-Menopausal Overweight and Obese Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 73
- 主要终点
- Gamma-Glutamyl Transferase (GGT)
研究概览
简要总结
This study aims to evaluate the effects of a 4 month Zumba training program on cardiometabolic, hormonal, inflammatory, hepatic, renal, and functional parameters in overweight and obese women. Participants will be classified according to menopausal status (pre- or post-menopausal) and randomly assigned to an exercise group or a non-exercise control group.
详细描述
Overweight and obesity are associated with metabolic dysregulation, hormonal imbalance, chronic inflammation, and reduced physical capacity. Zumba training is a dance-based aerobic exercise that can improve cardiovascular fitness, energy expenditure, and adherence to physical activity programs.
This study will assess the effects of a 4 month Zumba training program (4 sessions per week, 60 minutes per session) on: Body composition and anthropometric measures, Aerobic capacity, Hormonal profile, Lipid profile, Inflammatory biomarkers, Liver enzymes, Renal function markers, Electrolytes, Muscle enzymes, Pre- and post-training measurements will be taken under standardized conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-65 years
- •BMI ≥ 25 kg/m²
- •Pre-menopausal or post-menopausal (classified clinically)
- •Voluntary written informed consent
排除标准
- •Hormonal therapy or weight-loss medications
- •Endocrine diseases or chronic illness
- •Recent intense physical training (<48 hours before baseline)
结局指标
主要结局
Gamma-Glutamyl Transferase (GGT)
时间窗: Baseline and after 4 months of the intervention.
Serum GGT concentration measured in U/L.
Lactate Dehydrogenase (LDH)
时间窗: Baseline and after the 4 months of the intervention.
Serum LDH concentration measured in U/L.
Body Mass Index (BMI)
时间窗: Baseline and after 4 months of Zumba intervention.
BMI calculated as weight (kg) divided by height squared (m²).
Body Fat Percentage
时间窗: Baseline and after 4 months of Zumba intervention.
Total body fat measured by digital scale (Tanita BC-533).
Waist Circumference
时间窗: Baseline and after 4 months of Zumba intervention.
Measured at the narrowest point between the rib cage and iliac crest using a tape measure.
Waist-Hip Ratio
时间窗: Baseline and after 4 months of Zumba intervention.
Calculated by dividing waist circumference by hip circumference.
Hip Circumference
时间窗: Baseline and after 4 months of Zumba intervention.
Measured at the widest point of the hips using a tape measure.
Prolactin
时间窗: Baseline and after 4 months of the intervention.
Serum prolactin concentration (ng/mL).
Testosterone
时间窗: Baseline and after 4 months of the intervention.
Serum testosterone concentration (ng/dL).
Cortisol
时间窗: Baseline and after 4 months of the intervention.
Serum cortisol concentration (µg/dL).
Progesterone
时间窗: Baseline and after 4 months of the intervention.
Serum progesterone concentration (ng/mL).
Estradiol
时间窗: Baseline and after 4 months of the intervention.
Serum estradiol concentration (pg/mL).
Follicle-Stimulating Hormone (FSH)
时间窗: Baseline and after 4 months of the intervention.
Serum FSH concentration (mIU/mL).
Luteinizing Hormone (LH)
时间窗: Baseline and after 4 months of the intervention.
Serum LH concentration (mIU/mL).
Thyroid Stimulating Hormone (TSH)
时间窗: Baseline and after 4 months of the intervention.
Serum TSH concentration (µIU/mL).
Free Thyroxine (FT4)
时间窗: Baseline and after 4 months of the intervention.
Serum free T4 concentration (ng/dL).
Parathyroid Hormone (PTH)
时间窗: Baseline and after 4 months of the intervention.
Serum PTH concentration (pg/mL).
Total Cholesterol
时间窗: Baseline and after 4 months of the intervention.
Serum total cholesterol concentration (mg/dL).
High-Density Lipoprotein (HDL) Cholesterol
时间窗: Baseline and after 4 months of the intervention.
Serum HDL cholesterol concentration (mg/dL).
Low-Density Lipoprotein (LDL) Cholesterol
时间窗: Baseline and after 4 months of the intervention.
Serum LDL cholesterol concentration (mg/dL).
Triglycerides
时间窗: Baseline and after 4 months of the intervention.
Serum triglyceride concentration (mg/dL).
C-Reactive Protein (CRP)
时间窗: Baseline and after 4 months of the intervention.
Serum CRP concentration (mg/L).
Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline and after 4 months of the intervention.
ESR measured in mm/hr.
Complete Blood Count (CBC)
时间窗: Baseline and after 4 months of the intervention.
Includes neutrophils, lymphocytes, monocytes, eosinophils, basophils (cells/µL).
Alanine Aminotransferase (ALT)
时间窗: Baseline and after 4 months of the intervention.
Serum ALT concentration measured in U/L.
Aspartate Aminotransferase (AST)
时间窗: Baseline and after 4 months of the intervention.
Serum AST concentration measured in U/L.
Alkaline Phosphatase (ALP)
时间窗: Baseline and after 4 months of the intervention.
Serum ALP concentration measured in U/L.
Gamma-Glutamyl Transferase (GGT)
时间窗: Baseline and after the 4 months of the intervention.
Serum GGT concentration measured in U/L.
Lactate Dehydrogenase (LDH)
时间窗: Baseline and after 4 months of training.
Serum LDH concentration measured in U/L, indicator of muscle and tissue damage.
Bilirubin Total
时间窗: Baseline and after the 4 months of the intervention.
Total serum bilirubin concentration measured in mg/dL.
Bilirubin Direct
时间窗: Baseline and after the 4 months of the intervention.
Direct (conjugated) serum bilirubin concentration measured in mg/dL.
Creatinine
时间窗: Baseline and after 4 months of the intervention.
Serum creatinine concentration measured in mg/dL, indicator of kidney function.
Urea
时间窗: Baseline and after 4 months of the intervention.
Serum urea concentration measured in mg/dL, indicator of kidney function.
Uric Acid
时间窗: Baseline and after 4 months of the intervention.
Serum uric acid concentration measured in mg/dL, indicator of kidney function.
Sodium (Na)
时间窗: Baseline and after 4 months of the intervention.
Serum sodium concentration measured in mmol/L.
Potassium (K)
时间窗: Baseline and after 4 months of the intervention.
Serum potassium concentration measured in mmol/L.
Calcium (Ca)
时间窗: Baseline and after 4 months of training.
Serum calcium concentration measured in mg/dL.
Magnesium (Mg)
时间窗: Baseline and after 4 months of training.
Serum magnesium concentration measured in mg/dL.
Phosphate (PO₄)
时间窗: Baseline and after 4 months of training.
Serum phosphate concentration measured in mg/dL.
Creatine Phosphokinase (CPK)
时间窗: Baseline and after 4 months of training.
Serum CPK concentration measured in U/L, indicator of muscle damage.
次要结局
- Resting Heart Rate(Baseline and after 4 months of Zumba intervention.)
- Blood Pressure (Systolic and Diastolic)(Baseline and after 4 months of Zumba intervention.)
- 6-Minute Walk Test (6MWT) Distance(Baseline and after 4 months of Zumba intervention.)
研究者
Wissal Abassi
Principal Investigator
High Institute of Sports and Physical Education of Kef