Study on the Normative State and Inter- and Intra-individual Variation in Growth, Hematology, Hydration and Markers of Oxidation, Infection and Inflammation in Preschool Children With a Similar Dietary Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Urine Osmolality-3
研究概览
简要总结
This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment.
Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases.
OBJECTIVES PRINCIPAL OBJECTIVE
To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet.
SPECIFIC OBJECTIVES
- To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural.
- To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural.
- To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
- To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
- To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
- To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
- To explore intra-individual associations in variables of the same research component or different component variables.
详细描述
Please note protocol is also available in Spanish.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 23 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be attending one of the SOSEP systems assigned daycare centers
- •To maintain an attendance of 80% during the 8 weeks of the fieldwork
- •Aged 23 to 84 months
- •Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu.
排除标准
- •Children whose parents of caregivers did not sign a consent form
- •Children who refused to participate in the study
- •Children who refused to adhere to the collections routines.
结局指标
主要结局
Urine Osmolality-3
时间窗: 8th week of observation
Hydration Status= measured in 24-h urine through urine volume and osmolality in two different osmometers (Löser 815 and Osmomat 030). Results in mOsm/kg.
Urine Urea
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: urea (mg/l)
Urine Uric Acid
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: uric acid (mg/l)
Weight
时间窗: 7th week of observation
Growth, measured trough weight (kg)
Urine Osmolality-1
时间窗: 6th week of observation
Hydration Status= measured in 24-h urine through urine volume and osmolality in osmometer Model Löser 815. Results in mOsm/kg.
Urine Osmolality-2
时间窗: 7th week of observation
Hydration Status= measured in 24-h urine through urine volume and osmolality Osmometer Model Löser 815. Results in mOsm/kg.
Urine Phosphorus
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: inorganic phosphorus (mg/l)
Urine 8-Hydroxydeoxyguanosine
时间窗: 8th week of observation
Urine Oxidation biomarkers: 8-Hydroxydeoxyguanosine (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kits (JaICA, Nikken SEIL Co., Ltd, Catalog# IM-KOGHS 040914E, Shizouka, Japan).
Retinol
时间窗: 8th week of observation
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Retinol (mg/dl)
Hemoglobin
时间窗: 8th week of observation
Hemoglobin (mg/dl) measured in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango, Guatemala.
Height
时间窗: 7th week of observation
Growth, measured trough height (cm).
Urine Calcium
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: calcium (mg/l)
Superoxide Dismutase Activity
时间窗: 8th week of observation
Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Superoxide Dismutase Activity (U/g Hb)
Plasma Interleukin-1B
时间窗: 8th week of observation
Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-1B (pg/ml)
Saliva Interleukin-6
时间窗: 8th week of observation
Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-6 (pg/ml)
Giardiasis Infection Presence-2
时间窗: 8th week of observation
Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Urine Potassium
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: potassium (mg/l)
Urine Magnesium
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: magnesium (mg/l)
Catalase Activity
时间窗: 8th week of observation
Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system: Catalase Activity (nmol/seg/g Hb)
Plasma Interleukin-8
时间窗: 8th week of observation
Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-8 (pg/ml)
Plasma Interleukin-10
时间窗: 8th week of observation
Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-10 (pg/ml)
Saliva Interleukin-10
时间窗: 8th week of observation
Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system Saliva IL-10 (pg/ml)
Saliva Tumor Necrosis Factor-Alpha
时间窗: 8th week of observation
Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva Tumor Necrosis Factor-Alpha (pg/ml)
White Urine Cell Count
时间窗: 8th week of observation
White urine cell count (per field), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
Urine 15-f2t-Isoprostanes
时间窗: 8th week of observation
Urine Oxidation biomarkers: 15-f2t-Isoprostanes (ng/mL) Measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada using ELISA assay kit (Oxford Biomedical Research, Inc., Catalog # EA84.102606, Michigan, USA)
Urine Sodium
时间窗: 8th week of oservation
Urine solutes measured by the Scientific Instrumentation Center from the Granada University, Spain: sodium (mg/l)
Gluthathione Reductase
时间窗: 8th week of observation
Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Reductase Activity (umol/min/g Hb)
Alpha-tocopherol
时间窗: 8th week of observation
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Alpha-tocopherol (mg/l)
Saliva Interleukin-8
时间窗: 8th week of observation
Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-8 (pg/ml)
Intestinal Parasitosis
时间窗: 8th week of observation
Intestinal Parasitosis, measured by Biochemistry Laboratory, La Democracia Hospital, Quetzaltenango, Guatemala. Parasite cysts presence in feces.
Gluthathione Peroxidase
时间窗: 8th week of observation
Activity of antioxidant enzymes in red blood cells; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using ELISA system Gluthathione Peroxidase Activity (uU/g Hb)
Beta-Carotenes
时间窗: 8th week of observation
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Beta-carotenes (mg/l)
Plasma Interleukin-6
时间窗: 8th week of observation
Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma IL-6 (pg/ml)
Plasma Tumor Necrosis Factor-Alpha
时间窗: 8th week of observation
Plasma Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Plasma Tumor Necrosis Factor-Alpha (pg/ml)
Saliva Interleukin-1B
时间窗: 8th week of observation
Saliva Interleukines; measured at the Institute of Nutrition and Food Technology, Center of Biomedical Research, University of Granada, using the Luminex system: Saliva IL-1B (pg/ml)
Giardiasis Infection Presence-1
时间窗: 7th week of observation
Analyses done by ELISA assay kit (ProSpecT Giardia EZ, catalog #R2458596), absorbance (O.D)
Coenzyme Q9
时间窗: 8th week of observation
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q9 (mg/l)
Coenzyme Q10
时间窗: 8th week of observation
Content of antioxidant compounds in plasma; Scientific Instrumentation Center, University of Granada. Coenzyme Q10 (mg/l)
Fecal Calprotectin
时间窗: 8th week of observation
Fecal Calprotectin (mg/kg) measured using the ELISA assay kit from Calpro-Lab (Catalog # CAL0100).
White Blood Cell Count
时间窗: 8th week of observation
White blood cell count (cells/ul), to be determined in Biochemistry Laboratory in La Democracia Hospital, Quetzaltenango Guatemala.
次要结局
未报告次要终点
研究者
María José Soto
PhD student and nutrition researcher
Center for Studies of Sensory Impairment, Aging and Metabolism