Clinical trial NCT04252144: Study of Dietary Patterns and Food Diversity in Russian GERD Patients
Official title: Study of Dietary Patterns and Food Diversity in Russian GERD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal; Reflux With Esophagitis
Gastroesophageal Reflux
GERD
Heartburn
Non-erosive Reflux Disease
Esophagitis
Keywords: food diversity
dietary pattern
healthy eating pattern
oesophagitis
GERD
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Russian Science Foundation
First posted: 2020-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Dietary assessment with the use of computer-based food frequency questionnaire will be performed to patients with established diagnosis of gastroesophageal reflux disease in comparison to the representatives of a control group (without the disease).
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess food diversity and dietary patterns in Russian GERD patients

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* willingness to participate (signed the informed consent form);
* willingness to follow all the required procedures;

Exclusion Criteria:

* 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

Primary outcomes:
measure: grains consumption diversity
timeFrame: a month
measure: meat consumption diversity
timeFrame: a month
measure: poultry consumption diversity
timeFrame: a month
measure: fish consumption diversity
timeFrame: a month
measure: flour consumption diversity
timeFrame: a month
measure: vegetables consumption diversity
timeFrame: a month
measure: Fruits consumption diversity
timeFrame: a month
measure: Fats consumption diversity
timeFrame: a month
Secondary outcomes:
measure: GERD-associated dietary pattern
timeFrame: a year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Study officials:
affiliation: FRC nutrition and biotechnology
name: Vasily Isakov, MD, PhD, Professor, AGAF
role: STUDY_CHAIR
affiliation: FRC Nutrition and Biotechnology
name: Sergey Morozov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: