Estudio en Humanos Para la identificación de Biomarcadores de Actividad física Moderada y Sedentarismo y su Posible relación Con Determinantes genéticos e Indicadores Del Estado de Salud metabólica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
This clinical trial aims to recruit a core cohort of adults with normal weight, overweight, and obesity, but without other metabolic alterations, to undergo a six-month nutritional intervention. The main objective is to compare a genotype- and phenotype-based nutrition approach with a traditional nutrition plan adjusted only to phenotype. To evaluate the effectiveness of each type of intervention, anthropometric measurements and nutritional assessments will be collected at baseline, three months, and six months. In addition, plasma samples will be obtained to analyze clinical and non-clinical biomarkers, providing a more comprehensive evaluation of health status at baseline and after six months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 25 and 55 years; volunteers who sign the informed consent forms for sample collection and for participation in the study, after having read the information sheet of the research project; absence of known disease.
排除标准
- •participants younger than 25 years and older than 55 years; physically or legally incapacitated persons; pregnant or breastfeeding women; presence of blood-borne infectious diseases (HIV/AIDS, hepatitis, etc.); presence of diseases associated with a risk of complications during blood extraction (coagulation disorders, heart failure, etc.); individuals with diabetes, hypertension, grade II or higher obesity (BMI ≥35), or those receiving chronic medication (excluding contraceptives).
研究组 & 干预措施
Control
Participants assigned to this arm (initially comprising 50 individuals) received nutritional counseling to promote adherence to a standard Mediterranean diet, based on general healthy eating guidelines for the Spanish adult population, along with phenotype-tailored recommendations for physical activity.
干预措施: Diet (Other)
Personalized Nutrition
Participants in this arm were advised to follow a Mediterranean diet adapted through nutritional and physical activity recommendations tailored to their genetic profile, developed on the basis of a commercial nutrigenetic report.
干预措施: Diet (Other)
结局指标
主要结局
Body Mass Index
时间窗: Baseline, Month 3 of intervention, Month 6 (end) of intervention
BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²
Body Fat Percentage
时间窗: Baseline, Month 3 of intervention, Month 6 (end) of intervention
Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)
次要结局
- Body Weight(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Waist Circumference(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Hip Circumferenc(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Plasma Tumor necrosis factor alpha (TNF-α)(Baseline, Month 6 (end) of intervention)
- CUN-BAE(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Waist-to-hip ratio(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Waist-to-height ratio(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Plasma Leptin(Baseline, Month 6 (end) of intervention)
- Plasma Adiponectin(Baseline, Month 6 (end) of intervention)
- Adiponectin-Leptin Ratio(Baseline, Month 6 (end) of intervention)
- Plasma Interleukin-6 (IL-6)(Baseline, Month 6 (end) of intervention)
- Plasma Triglycerides(Baseline, Month 6 (end) of intervention)
- Plasma Total Cholesterol(Baseline, Month 6 (end) of intervention)
- Plasma High-Density Lipoprotein (HDL) cholesterol(Baseline, Month 6 (end) of intervention)
- Plasma Low-Density Lipoprotein (LDL) cholesterol(Baseline, Month 6 (end) of intervention)
- Non-HDL Cholesterol(Baseline, Month 6 (end) of intervention)
- Fasting glucose(Baseline, Month 6 (end) of intervention)
- Fasting insulin(Baseline, Month 6 (end) of intervention)
- Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, Month 6 (end) of intervention)
- Insulin sensitivity will be estimated using the Quantitative Insulin Sensitivity Check Index (QUICKI)(Baseline, Month 6 (end) of intervention)
- Plasma Irisin(Baseline, Month 6 (end) of intervention)
- Plasma Fibroblast growth factor 21 (FGF-21)(Baseline, Month 6 (end) of intervention)
- Plasma Uric Acid(Baseline, Month 6 (end) of intervention)
- Dietary intake assessment(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Physical Activity Level(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Adherence to the Mediterranean diet(Baseline, Month 3 of intervention, Month 6 (end) of intervention)
- Plasma Gamma-glutamyltransferase (γ-glutamyltransferase, GGT)(Baseline, Month 6 (end) of intervention)
- Plasma alanine transaminase (ALT)(Baseline, Month 6 (end) of intervention)