Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Maturity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in fasting glucose
研究概览
简要总结
The SACIANS study (Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Middle-Aged Adults) aims to evaluate the combined effect of commercially available food supplements on satiety and lipid metabolism in adults over 45 years of age who are overweight.
This 12-week randomized controlled clinical trial will include 80 participants divided into two parallel groups: a control group without supplementation and an experimental group receiving a specific combination of food supplements with proven nutritional safety and previous evidence of functional effects on metabolism.
Primary outcomes include changes in biochemical parameters related to lipid metabolism (cholesterol profile, triglycerides, and glucose), as well as markers of oxidative stress and inflammation. Secondary outcomes include variations in body composition, perceived satiety, emotional well-being, sleep quality, and lifestyle habits such as diet adherence and physical activity.
The study will be conducted at the University of Alicante and the EIEH Clinic (Elche Institute of Exercise and Health), following the principles of the Declaration of Helsinki. The goal is to provide scientific evidence on the synergistic potential of existing food supplement combinations to promote metabolic balance and healthy aging.
详细描述
Overweight and metabolic alterations in adults over 45 years old represent a growing public health concern, frequently associated with conditions such as type 2 diabetes, dyslipidemia, and cardiovascular disease. Although numerous food supplements are currently available on the market with reported effects on satiety or lipid oxidation, most lack personalization and evidence regarding their combined effects.
The SACIANS project (Advanced Strategy of Food Supplements for the Optimization of Satiety and Lipid Metabolism in Middle-Aged Adults) is a 12-week, randomized, controlled, parallel-group clinical trial designed to evaluate the efficacy of different combinations of commercially available food supplements on metabolic and emotional parameters in adults with overweight or mild obesity.
Participants (n = 80; 40 per group) will be randomly assigned to one of two arms:
Control group: No supplementation.
Experimental group: Daily intake of a combination of registered food supplements selected based on their nutritional profile, labeling, safety, and prior evidence of functional efficacy.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to group allocation during data analysis to minimize bias. Given the nature of the intervention (supplementation vs. no supplementation), participant blinding is not applicable.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 45 years
- •Body Mass Index (BMI) between 25.0 and 34.9 kg/m²
- •Signed informed consent form
排除标准
- •Pregnancy or breastfeeding
- •Participation in similar studies within the previous 3 months
- •Current use of supplements or medications that may affect metabolism
- •Joint injury or physical limitation that restricts participation
- •Clinical conditions that could prevent adherence to the study protocol
结局指标
主要结局
Change in fasting glucose
时间窗: Baseline and after 12 weeks of intervention
Difference in fasting blood glucose concentration after the intervention period.
Change in total cholesterol
时间窗: Baseline and after 12 weeks of intervention
Variation in plasma total cholesterol concentration after 12 weeks of supplementation.
Change in LDL-cholesterol
时间窗: Baseline and after 12 weeks of intervention
Variation in low-density lipoprotein (LDL) cholesterol levels to evaluate lipid metabolism response.
Change in perceived satiety levels
时间窗: Baseline and after 12 weeks of intervention
Evaluation of subjective satiety using a validated visual analog scale (VAS) for appetite and fullness.
Change in HDL-cholesterol
时间窗: Baseline and after 12 weeks of intervention
Variation in high-density lipoprotein (HDL) cholesterol levels as an indicator of cardiovascular health.
Change in triglycerides
时间窗: Baseline and after 12 weeks of intervention
Variation in plasma triglyceride concentration
次要结局
- Change in body fat percentage(Baseline and after 12 weeks of intervention)
- Change in lean mass(Baseline and after 12 weeks of intervention)
- Change in C-reactive protein (CRP)(Baseline and after 12 weeks of intervention)
- Change in malondialdehyde (MDA)(Baseline and week 12)
- Change in total antioxidant capacity (TAC)(Baseline and week 12)
- Change in perceived stress (PSS questionnaire)(Baseline and week 12)
- Change in sleep quality (PSQI)(Baseline and week 12)
- Change in Mediterranean diet adherence (PREDIMED score)(Baseline and week 12)
- Change in physical activity level (IPAQ questionnaire)(Baseline and week 12)
- Change in body weight(Baseline and after 12 weeks of intervention)
- Change in body fat percentage(Baseline and after 12 weeks of intervention)
- Change in lean mass(Baseline and after 12 weeks of intervention)
- Change in C-reactive protein (CRP)(Baseline and after 12 weeks of intervention)
- Change in malondialdehyde (MDA)(Baseline and week 12)
- Change in total antioxidant capacity (TAC)(Baseline and week 12)
- Change in perceived stress (PSS questionnaire)(Baseline and week 12)
- Change in sleep quality (PSQI)(Baseline and week 12)
- Change in Mediterranean diet adherence (PREDIMED score)(Baseline and week 12)
- Change in physical activity level (IPAQ questionnaire)(Baseline and week 12)
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Catedrático Ciencias de la Salud
University of Alicante