Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Sponsor

Russian Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04252144

Collaborator

Russian Science Foundation (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal; Reflux With Esophagitis Gastroesophageal Reflux GERD Heartburn Non-erosive Reflux Disease Esophagitis	Procedure: Dietary assessment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

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).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).

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Actual Study Start Date :

Jan 30, 2020

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GERD Patients with verified gastroesophageal reflux disease	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. Other Names: Food frequency questionnaire
Other: Contol Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination	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. Other Names: Food frequency questionnaire

Arm

Intervention/Treatment

Experimental: GERD

Patients with verified gastroesophageal reflux disease

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.

Other Names:

Food frequency questionnaire

Other: Contol

Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination

Procedure: Dietary assessment

Other Names:

Food frequency questionnaire

Outcome Measures

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology and Hepatology, FRC Nutrition and Biotechnology	Moscow		Russian Federation	115446

Sponsors and Collaborators

Russian Academy of Medical Sciences
Russian Science Foundation

Investigators

Study Chair: Vasily Isakov, MD, PhD, Professor, AGAF, FRC nutrition and biotechnology
Principal Investigator: Sergey Morozov, MD, PhD, FRC Nutrition and Biotechnology