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

Nutrition Institute, Slovenia

Status

Completed

Conditions

Protein Deficiency

Vitamin B 12 Deficiency

Vitamin d Deficiency

Treatments

Dietary Supplement: Use of placebo food supplement

Dietary Supplement: Use of food supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05661006

2020/1-ET-SK

Details and patient eligibility

About

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.

Full description

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?

Enrollment

40 patients

Sex

All

Ages

65 to 95 years old

Volunteers

Accepts Healthy Volunteers

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