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 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT05661006
Eligibility Criteria:
Inclusion criteria:
* Subject Informed consent form (ICF) is singed
* Aged at least 65 at the time of the signature of ICF
* A body mass index lower than 32 kg/m2
* Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study
* Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)
Exclusion criteria:
* Medical treatment with Vitamin D and/or Vitamin B12
* Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months
* Known drug and/or alcohol abuse
* Known lactose/gluten intolerances/food allergies
* Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal
* Have chronic bowel disease (ulcerative colitis, Chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum)
* Have acute gastrointestinal infection with vomiting and / or diarrhea
* Have planned general anaesthesia or colonoscopy at the time of the study
* Have malabsorption syndrome
* Less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
* Have stomach or bowel resection
* Do not have neat and functional teeth
* Take regular or occasional laxative products
* Use antacids (Rupurut / Rutacid / Talcit)
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
95 Years
Study:
NCT05661006
Study Brief:
Protocol Section:
NCT05661006