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

Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults

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.

The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?

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