Clinical trial NCT05293769: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects, IBS patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations
timeFrame: 2 years
measure: Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations
timeFrame: 2 years
measure: Comparison of the degree of physical activity and IBS symptom severity in different populations
timeFrame: 2 years
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References: