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临床试验/NCT05293769
NCT05293769招募中不适用

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

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 65 years;
  • Provide written informed consent;
  • Living in Belgium

排除标准

  • 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.

结局指标

主要结局

To validate the newly developed food frequency questionnaire against the standard 4-day food diary across different populations

时间窗: 2 years

次要结局

  • Comparison of dietary and FODMAP intake in IBS vs. non-IBS patients in different populations(2 years)
  • Comparison of the degree of physical activity in IBS vs. non-IBS patients in different populations(2 years)
  • Comparison of the degree of physical activity and IBS symptom severity in different populations(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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