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:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT02450227
Eligibility Criteria:
List of inclusion criteria:
* Healthy adults (18-80 years old)
* Body Mass Index (BMI) between 18,9-28
* Normal fasting blood glucose (BS) (1,9-5,6 mmol/L)
* Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).
List of exclusion criteria:
* Intestinal diseases (among healthy controls), systemic infections, psychiatric disorders, metabolic diseases (incl. diabetes), and any clinical condition/circumstance which assessed by the study official makes the person unfit for participation in the trial.
* Patients diagnosed with short bowel syndrome (SBS).
* Chronic or frequent use of medication. Primarily consumption of drugs with known effect/side effects on fat absorption. Further, anticoagulants (Marevan) and systemic treatment with glucocorticoids.
* Have or have had a drug addiction
* Smokers
* Alcohol consumption beyond the recommended (7/14 units per week for women/men, respectively)
* Intake of vitamins or other supplements (3 months before the study and during the study) (healthy controls). Subjects from the patient group included only with stable intake of dietary supplements through the last 3 months.
* Sampling or donation of larger amount of blood e.g. as blood donors or to other scientific experiments from 3 months before the study until its completion.
* allergy or intolerance to any of the foods included in the study.
* Women who are nursing, pregnant or planning pregnancy
* Not able to comply with the procedures protocol.
* Macular degeneration to a degree greeter than or equal to a surface area with one or more drusen larger than 125 microns in diameter in at least one eye.
* Cataracts, macular- or other ocular disease, preventing depiction of xanthophyll pigment.
The following separate registered information was additionally recorded for short bowel/ileostomy patients:
* Time since operation (stable, \>1 year post operation)
* Type of disease/background for operation
* Intestinal anatomy (inclusive length and type of residual intestine)
* Type and doses of vitamin and other types of supplementation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02450227
Study Brief:
Protocol Section:
NCT02450227