"Investigación y Desarrollo de Nuevos Productos Alimentarios Para la elaboración de Una Cesta Saludable Para alimentación Infantil": MEDKIDS. Intervención Nutricional Con Productos de Pan y bollería.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Changes in body weight
研究概览
简要总结
The goal of this randomized crossover clinical trial is to evaluate the effect of an intervention with nutritionally improved bread and bakery products on body composition and metabolic health in children aged 6 to 12 years with overweight or obesity.
详细描述
The main questions it aims to answer are:
- Does consumption of reformulated bread and bakery products improve body composition compared to conventional products?
- Does the intervention improve lipid profile, inflammatory markers, gastrointestinal satiety-related peptides, and gut microbiota composition?
Researchers will compare conventional bakery products with reformulated products developed within the MEDKIDS project to determine their effects on anthropometric parameters, blood biomarkers, satiety, and intestinal microbiota.
Participants will:
- Follow a Mediterranean diet-based nutritional intervention with a 20% energy restriction adapted individually
- Consume either conventional or reformulated bread and bakery products during two 8-week intervention periods separated by a 5-week washout
- Undergo anthropometric assessments and blood, urine, and stool sample collection at the beginning and end of each period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label dietary intervention; masking is not feasible due to the nature of the food products.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12 years.
- •Overweight or obesity defined according to Cole et al. criteria.
- •Willingness and commitment to consume the study bread and bakery products as part of the nutritional intervention.
- •Written informed consent provided by a parent or legal guardian.
排除标准
- •Diagnosed disorders related to glucose metabolism (e.g., diabetes mellitus).
- •Celiac disease.
- •Gastrointestinal disorders, including inflammatory bowel disease.
- •Current medical or pharmacological treatment that may interfere with the study outcomes.
结局指标
主要结局
Changes in body weight
时间窗: Baseline and end of each 8-week intervention period
Change in body weight using bioelectrical impedance analysis with Tanita BC 780 MA scale. Unit of measure: kg
Change in height
时间窗: Baseline and end of each 8-week intervention period
Change in height measured using a Seca 225 precision stadiometer according to standardized anthropometric procedures. Unit of measure: cm
Change in body mass index
时间窗: Baseline and end of each 8-week intervention period
Change in body mass index calculated from body weight and height. Unir of measure: kg/m².
Change in body fat mass
时间窗: Baseline and end of each 8-week intervention period
Change in body fat mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: kg
Change in lean body mass
时间窗: Baseline and end of each 8-week intervention period
Change in lean body mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: Kg.
Change in total body water
时间窗: Baseline and end of each 8-week intervention period
Change in total body water measured using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unir of measure: %
Changes in triceps and subscapular skinfold thickness
时间窗: Baseline and end of each 8-week intervention period
Change in triceps and subscapular skinfold thickness measured in millimeters using a Holtain skinfold caliper according to standardized anthropometric procedures and International Society for the Advancement of Kinanthropometry (ISAK) recommendations. Three measurements will be performed.
Changes in blood biochemical, lipid and inflammatory parameters
时间窗: Baseline and end of each 8-week intervention period
Changes in blood chemical, lipid, and inflammatory parameters measured from fasting blood samples. Biochemical parameters include glucose, total proteins, calcium, iron, and zinc concentrations. Lipid parameters include total cholesterol, HDL cholesterol, LDL cholesterol triglycerides, apolipoprotein A1, and apolipoprotein B. Inflammatory parameters include C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), complement component 3 (C3), and complement component 4 (C4).
Changes in gut microbiota composition and diversity
时间窗: Baseline and end of each 8-week intervention period
Changes in gut microbiota composition and diversity assessed from stool samples using metagenomic analysis following consumption of nutritionally improved versus conventional bread and bakery products.
Changes in satiety-related measures
时间窗: Baseline and end of each 8-week intervention period
Changes in circulating satiety-related gastrointestinal hormones measured from fasting blood samples. Gastrointestinal hormones include insulin, leptin, ghrelin, glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), and glucagon-like peptide-1 (GLP-1).
Change in arm, waist and hip circumference
时间窗: Baseline and end of each 8-week intervention period
Change in arm, waist and hip circumference circumference measured in centimeters using a measuring tape according to standardized anthropometric procedures and International Society for the Advancement of Kinanthropometry (ISAK) recommendations. Three measurements will be performed.
次要结局
- Changes in sensory acceptability(Baseline and week 8)