Study of Dietary Patterns and Food Diversity in Russian GERD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- grains consumption diversity
研究概览
简要总结
The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients
详细描述
The study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). Only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or Barrett's oesophagus). Taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in Russian GERD patients could partly fill in the gap of knowledge on this particular matter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to participate (signed the informed consent form);
- •willingness to follow all the required procedures;
排除标准
- •Pregnant or breast-feeding females;
- •Neoplasms, current or by the medical history (except local skin cancer successfully treated);
- •History of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present);
- •Co-morbid conditions which can influence or mask the symptoms of GERD (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc);
- •the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: NSAIDs, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug;
- •the use of medications that influence gastric secretion at the time of enrolment and during 2 week before it;
- •any condition of the patient which makes the participation of the patient in the study unreasonable or put him at risk of the condition's exacerbation
结局指标
主要结局
grains consumption diversity
时间窗: a month
Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period
meat consumption diversity
时间窗: a month
Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period
Fruits consumption diversity
时间窗: a month
Mean number of different types of fruits consumed as is or in the form of different foods or food products
Fats consumption diversity
时间窗: a month
Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period
poultry consumption diversity
时间窗: a month
Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period
fish consumption diversity
时间窗: a month
Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period
vegetables consumption diversity
时间窗: a month
Mean number of different types of vegetables consumed as is or in the form of different foods or food products
flour consumption diversity
时间窗: a month
Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period
次要结局
- GERD-associated dietary pattern(a year)
研究者
Vasily Isakov
MD, PhD, Professor, AGAF
Russian Academy of Medical Sciences