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Study of Dietary Patterns and Food Diversity in Russian GERD Patients

Primary Purpose

Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux, GERD

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Dietary assessment
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal; Reflux With Esophagitis focused on measuring food diversity, dietary pattern, healthy eating pattern, oesophagitis, GERD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gastroenterology and Hepatology, FRC Nutrition and BiotechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

GERD

Contol

Arm Description

Patients with verified gastroesophageal reflux disease

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
vegetables consumption diversity
Mean number of different types of vegetables consumed as is or in the form of different foods or food products
Fruits consumption diversity
Mean number of different types of fruits consumed as is or in the form of different foods or food products
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

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2020
Last Updated
February 2, 2022
Sponsor
Russian Academy of Medical Sciences
Collaborators
Russian Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04252144
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences
Collaborators
Russian Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal; Reflux With Esophagitis, Gastroesophageal Reflux, GERD, Heartburn, Non-erosive Reflux Disease, Esophagitis
Keywords
food diversity, dietary pattern, healthy eating pattern, oesophagitis, GERD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GERD
Arm Type
Experimental
Arm Description
Patients with verified gastroesophageal reflux disease
Arm Title
Contol
Arm Type
Other
Arm Description
Mostly healthy subjects who have no symptoms and other manifestations of gastroesophageal reflux disease by complex examination
Intervention Type
Procedure
Intervention Name(s)
Dietary assessment
Other Intervention Name(s)
Food frequency questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
grains consumption diversity
Description
Mean number of different types of grains consumed in form of different foods or food products a month during 12-months period
Time Frame
a month
Title
meat consumption diversity
Description
Mean number of different types of meat consumed in form of different foods or food products a month during 12-months period
Time Frame
a month
Title
poultry consumption diversity
Description
Mean number of different types of poultry consumed in form of different foods or food products a month during 12-months period
Time Frame
a month
Title
fish consumption diversity
Description
Mean number of different types of fish consumed in form of different foods or food products a month during 12-months period
Time Frame
a month
Title
flour consumption diversity
Description
Mean number of different types of flours consumed in form of different foods or food products a month during 12-months period
Time Frame
a month
Title
vegetables consumption diversity
Description
Mean number of different types of vegetables consumed as is or in the form of different foods or food products
Time Frame
a month
Title
Fruits consumption diversity
Description
Mean number of different types of fruits consumed as is or in the form of different foods or food products
Time Frame
a month
Title
Fats consumption diversity
Description
Mean number of different types of fats consumed in the form of different foods or food products a month by 12 month period
Time Frame
a month
Secondary Outcome Measure Information:
Title
GERD-associated dietary pattern
Description
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.
Time Frame
a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Morozov, MD, PhD
Phone
+79104681801
Email
morosoffsv@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vasily Kropochev, MD
Phone
+74997943572
Email
followkropochev@ya.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasily Isakov, MD, PhD, Professor, AGAF
Organizational Affiliation
FRC nutrition and biotechnology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergey Morozov, MD, PhD
Organizational Affiliation
FRC Nutrition and Biotechnology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Morozov, MD, PhD
Phone
+74996131091
Email
84996131091@mail.ru
First Name & Middle Initial & Last Name & Degree
Vasily Kropochev, MD
Phone
+74997943572
Email
followkropochev@ya.ru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://ion.ru

Learn more about this trial

Study of Dietary Patterns and Food Diversity in Russian GERD Patients

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