Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMA… (NCT05293769) | Clinical Trial Compass
RecruitingNot Applicable
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
Belgium400 participantsStarted 2022-10-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations