Study of Dietary Patterns and Food Diversity in Russian GERD Patients

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

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux; Esophagitis; GERD; Heartburn; Non-erosive Reflux Disease; Gastroesophageal; Reflux With Esophagitis
• Intervention / Treatment: Procedure: Dietary assessment

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vasily Kropochev, MD; Phone Number: +74997943572; Email: followkropochev@ya.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Recruiting
    • Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
    • Contact: Vasily Kropochev, MD; Phone Number: +74997943572; Email: followkropochev@ya.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2020
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: GERD; dietary pattern; oesophagitis; food diversity; healthy eating pattern
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Heartburn; Esophagitis
• Other Study ID Numbers: 19-76-30014 GERD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data may be shared by request after study completion, except subjects' personal (identification) information
• IPD Sharing Time Frame: After the study completion, available for 2 years
• IPD Sharing Access Criteria: By request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No