Dieta Sin Gluten Equilibrada y Segura: Estudio De Biomarcadores y De Los Factores Determinantes Para Alcanzar El Equilibrio Nutricional y La Ausencia de Síntomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Dietary habits measurement
研究概览
简要总结
The only treatment for celiac disease (CD) consists of following a strict lifelong gluten-free diet, which may lead to potential dietary imbalances and associated diseases. Although individualized dietary counseling should be mandatory for people with celiac disease, they often do not receive this information, and there are few specific biomarkers that provide information about their progression and nutritional status.
Moreover, in the classic form of CD, gastrointestinal symptoms caused by gluten ingestion predominate. One might assume that removing this protein from the diet would lead to the complete remission of these symptoms; however, it has been shown that this is not always the case. Therefore, research into other possible dietary triggers of persistent symptoms is of great interest (including FODMAPs, ATIs, or histamine).
On the other hand, individuals within the celiac and gluten-sensitive (C-GS) community sometimes feel misunderstood by society, which makes greater education necessary both for this group and for their surroundings (the general population) to ensure their full social inclusion.
This project aims to improve the quality of life of people with C-GS by acting within the healthcare setting through dietary intervention and nutritional education; from a scientific perspective, by investigating possible causes of their symptoms and identifying biomarkers to help monitor their treatment and progression; and from a social perspective, by promoting knowledge about CD and the gluten-free diet among the general population. It also provides new technological tools for self-care and clinician-patient communication.
详细描述
GENERAL AND SPECIFIC OBJECTIVES
The aim of this project is to improve the quality of life of people with celiac disease-gluten sensitivity (CD-GS) by studying factors that may determine the success of a gluten-free diet (GFD). To this end, the following general (G) and specific (E) objectives have been established:
G1. Improvement of software for nutritional assessment and safety of the gluten-free diet.
Since removing gluten from the diet is not an easy task and often leads to dietary imbalance and risk of unintentional consumption, the goal is to enhance the GlutenFreeDiet software by incorporating new features, a wider range of specific gluten-free foods, and a more appealing and intuitive graphic design. In addition, a tool will be developed to allow users to identify, measure, and provide data on the FODMAP, ATI, and histamine content of foods, facilitating progress in determining the relationship between these compounds and persistent symptoms in individuals with CD following a GFD.
Specific objectives under G1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants receive nutritional assesment from care providers (dietitians) and investigators analyze data collected from participants and biomarkers in collected serum, urine and stool.
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a child who volunteered to participate in the intervention study.
- •Being a child with a recent diagnosis of CD.
- •Being willing to follow a GFD.
排除标准
- •A history of chronic diseases (e.g., cardiovascular diseases, diabetes, hyperthyroidism/hypothyroidism, hypercholesterolemia, hypertriglyceridemia, or hypertension) or other digestive pathologies requiring specific dietary advice.
- •Lacking a desire to be part of the intervention.
结局指标
主要结局
Dietary habits measurement
时间窗: 1 year
The consumption of all foods of daily and weekly intake was measured after the intervention. the consumption of foods was measured as protions /day or portions/week.
Gastrointestinal and Extra-intestinal sympthoms measurements
时间窗: 1 year
The quantity and the intensity of gastro intestinal symptoms were measured with Gastrointestinal Symptom Rating Scale (GSGR) questionnaire. The GSGR questionnaire assesses 15 gastrointestinal and diet-related symptoms at different levels of intensity. When symptom burden is evaluated as the number of reported symptoms, the total score ranges from 0 to 15, with values close to 0 indicate absence of symptoms and values close to 15 all assessed symptoms. When symptom severity is considered, the total score ranges from 0 to 90, with values close to 0 indicating few symptoms at low intensity and values close to 90 many symptoms at high intensity. Extra intestinal symptoms presence was measured with a questionnaire that was adapted from a questionnaire used to measure 12 of these sympthoms in Non Gluten Celiac Sensitivity, 0 indicates no sympthoms and 12 all of them.
Quality of life measurement
时间窗: 1 year
A total score of quality of life as well as the score in three subscales (having celiac disease, Diet and communication were analyzed. The scales went from 1 (very poor queality of life) to 5 (very good quality of life) points.
Biomarkers analysis
时间窗: 1 year
FABP and citrulline were measured in serum through ELISA method.
Serum protein and cytokine expression measurement
时间窗: 1 year
92 serum proteins were analyzed using Proximity Extension Assay (PEA) technology, implemented through the Olink® Target 96 Inflammation panel.
miRNA analysis
时间窗: 1 year
A library of 644 circulating miRNAs were measured. miRNA sequencing libraries were prepared using the Lexogen Small RNA-Seq Library Prep Kit.
Gluten Inmunogenic Peptides (GIP) quantification
时间窗: 1 year
GIP presence in urine and stool was measured by ELISA techniques.
次要结局
未报告次要终点
研究者
Arrate Lasa
Principal Investigator
University of the Basque Country (UPV/EHU)