Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Not Applicable

• Conditions: Gastroesophageal; Reflux With Esophagitis; Non-erosive Reflux Disease; Gastroesophageal Reflux; Heartburn; GERD; Esophagitis

• Registration Number: NCT04252144
• Lead Sponsor: Russian Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2020-01-30
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
grains consumption diversity	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	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	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	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	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	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	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	a month	Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period

Secondary Outcome Measures

Name	Time	Method
GERD-associated dietary pattern	a year	complex of nutrients and/or foods (food products) which correlates with presence of GERD. The correlation coefficients for each food item is range in the order of significance and direction of the relationship and in accordance to the amount of the product consumed, than is formed to the integral mean.

Trial Locations

Locations (1)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology; 🇷🇺 Moscow, Russian Federation