Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Gastroesophageal Reflux Clinical Trial

Official title:

Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252144
• Other study ID #: 19-76-30014 GERD
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Russian Academy of Medical Sciences
• Contact: Sergey Morozov, MD, PhD
• Phone: +79104681801
• Email: morosoffsv[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Dietary assessment
Dietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions.

Locations

Country	Name	City	State
Russian Federation	Gastroenterology and Hepatology, FRC Nutrition and Biotechnology	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences	Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grains consumption diversity	Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period	a month
Primary	meat consumption diversity	Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period	a month
Primary	poultry consumption diversity	Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period	a month
Primary	fish consumption diversity	Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period	a month
Primary	flour consumption diversity	Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period	a month
Primary	vegetables consumption diversity	Mean number of different types of vegetables consumed as is or in the form of different foods or food products	a month
Primary	Fruits consumption diversity	Mean number of different types of fruits consumed as is or in the form of different foods or food products	a month
Primary	Fats consumption diversity	Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period	a month
Secondary	GERD-associated dietary pattern	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.	a year