Study of Dietary Patterns and Food Diversity in Russian GERD Patients

NCT04252144 | Unknown DMC

• 1 other identifier: 19-76-30014 GERD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

food diversity; dietary pattern; healthy eating pattern; oesophagitis; GERD

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• GERD-associated dietary pattern

  a year

Study Arms (2)

GERD

EXPERIMENTAL

Patients with verified gastroesophageal reflux disease

Procedure: Dietary assessment

Contol

OTHER

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

Procedure: Dietary assessment

Interventions

Dietary assessment PROCEDURE

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.

Also known as: Food frequency questionnaire

Contol; GERD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willingness to participate (signed the informed consent form);
• willingness to follow all the required procedures;

You may not qualify if:

• 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

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead
• Russian Science Foundation: collaborator

Study Sites (1)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, 115446, Russia

RECRUITING

MeSH Terms

Conditions

Esophagitis, Peptic; Gastroesophageal Reflux; Heartburn; Non-Erosive Reflux Disease; Esophagitis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Esophageal Motility Disorders; Deglutition Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Vasily Isakov, MD, PhD, Professor, AGAF

  FRC nutrition and biotechnology

  STUDY CHAIR

• Sergey Morozov, MD, PhD

  FRC Nutrition and Biotechnology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Morozov, MD, PhD

CONTACT

+79104681801; morosoffsv@mail.ru

Vasily Kropochev, MD

CONTACT

+74997943572; followkropochev@ya.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, AGAF

Model Details: 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).

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: January 30, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study completion, available for 2 years
• Access Criteria: By request

Locations

RU (1)