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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT03272867
Eligibility Criteria:
Inclusion Criteria:
1. Healthy volunteer aged ≥ 60 to ≤ 70
2. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)
3. Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).
4. Two weeks before the start and during the study no use of over the counter medication, prescribed medication, herbal medication or dietary supplements which in the investigator's opinion could affect study results, or which could be affected by the study product (i.e. absorption of oral medication will be influenced by D-Mannitol). Exception for sporadic use of paracetamol and/or treating an AE.
5. Able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests.
6. Voluntary signed written informed consent form (ICF) before the start of the pilot.
Exclusion Criteria:
1. BMI \< 25 or \> 30 kg/m2
2. Not being able to fast overnight (12 hours)
3. Diabetes mellitus
4. Gastrointestinal disorders
5. Undergone digestive tract surgery (except appendectomy)
6. Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study)
7. Weed smoking
8. Donation of blood within the last 3 months prior to admission to the clinic
9. Participation to another clinical study within 90 days before enrolment
10. Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening
11. Positive drug screen or alcohol breath test at D-1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT03272867
Study Brief:
Protocol Section:
NCT03272867