Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs in Different Populations, and Relationship With IBS Symptoms and the Degree of Self-assessed Physical Activity

Irritable Bowel Syndrome Clinical Trial

Official title:

Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) in Different Populations, and Relationship With IBS (Inflammatory Bowel Syndrome) Symptoms and the Degree of Self-assessed Physical Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293769
• Other study ID #: FaST
• Status: Recruiting
• Start date: October 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Sébastien Kindt
• Phone: +32 2 477
• Email: Sebastien.kindt[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. In order to validate the FFQ in different populations, participants will be recruited from university students, staff of UZ Brussel and VUB, and from the community by advertisement (including social media). IBS patients will be recruited from the gastro-enterology outpatient clinic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years;

• Provide written informed consent;

• Living in Belgium

Exclusion Criteria:

• Diet < 8 weeks prior to participation;

• Known or suspected eating disorder;

• Major psychiatric disorder;

• Known gastro-intestinal disease (IBS is allowed);

• Any malignancy in the past 3 years (basocellular carcinoma is allowed);

• Chemotherapy in the past 6 months;

• Infectious gastro-enteritis in the past 6 months (infectious gastro-enteritis defined as the concurrent presence of one of the following signs during 2 or more consecutive days: fever, vomiting, sudden onset of diarrhea, hospitalization because of these symptoms);

• Previous abdominal surgery (appendectomy and cholecystectomy are allowed);

• Alcohol abuse defined as > 14 U per week;

• Use of illicit drugs;

• Intake of drugs with known major gastro-intestinal side effects.

• Initiation of neuromodulators less than 3 months before participation. Neuromodulators are allowed when taken at a stable dose for at least 3 months;

• Pregnancy.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• questionnaire
questionnaire will be filled in by all participants

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations		2 years
Secondary	Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations	differences in number and type of FODMAP intake between groups	2 years
Secondary	Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations	differences and correlation of IPAQ (International Physical Activity Questionnaire) scores between groups, IPAQ evaluates the level of physical activity. Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more	2 years
Secondary	Comparison of the degree of physical activity and IBS symptom severity in different populations	differences and correlation of IPAQ scores between groups; IPAQ evaluates the level of physical activity. Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more	2 years