ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults

Conditions: Vitamin d Deficiency, Vitamin B 12 Deficiency, Protein Deficiency

Summary

The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.

Eligibility Criteria

Inclusion criteria:Subject Informed consent form (ICF) is singedAged at least 65 at the time of the signature of ICFA body mass index lower than 32 kg/m2Plasma 25-OH-Vitamin D level below 20 µg/LWilling to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the studyWilling 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 B12Supplementation with protein, vitamin D and/or vitamin B12 during least 2 monthsKnown drug and/or alcohol abuseKnown lactose/gluten intolerances/food allergiesInadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawalHave 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 diarrheaHave planned general anaesthesia or colonoscopy at the time of the studyHave malabsorption syndromeLess than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)Have stomach or bowel resectionDo not have neat and functional teethTake regular or occasional laxative productsUse antacids (Rupurut / Rutacid / Talcit)Mental incapacity that precludes adequate understanding or cooperationParticipation in another investigational study

Source: ClinicalTrials.gov (NCT05661006). StuddyBuddy aggregates publicly available trial information.