Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01802112
Eligibility Criteria:
Inclusion Criteria:
* Subjects of both sexes (men and women) between 18 and 30 years old of Caucasian race selected from the general population
* Subjects capable of understanding the clinical study, willing to provide written informed consent and to fulfil the procedures and requirements of the study.
Exclusion Criteria:
* Diagnosis of a BMI ≥ 30 Kg/m2.
* Individuals with a daily defecation habit.
* Subjects with a history of any digestive disease or who have undergone gastrointestinal surgery (excluding appendicectomy or herniorrhaphy), abdominal surgery in the last two years or any recent major extra-abdominal surgery.
* Subjects with diabetes, hypothyroidism or hyperthyroidism.
* Subjects with a history of systemic disease that might effect gut motility.
* Subjects on dietary treatment and/or drugs that effect body weight or appetite.
* Individuals that have had any change in dietary habit in the last 2 months.
* Subjects with a history of drug or alcohol abuse, or other substances or factors that might limit their ability to cooperate during the study.
* Subjects with bowel habits affected by stress.
* Subjects taking medication or drugs that alter gut motility.
* Pregnant women.
* Subjects that have stopped smoking in the last 6 months or who intend to give up smoking during the study.
* Subjects with allergies or eating disorders.
* Subjects that consume an excessive amount of alcohol (\>3 glasses of wine or beer per day)
* Individuals that engage in physical exercise two or more times per week.
* Subjects whose condition makes them ineligible to take part in the study, according to the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT01802112
Study Brief:
Protocol Section:
NCT01802112