Clinical trial NCT05661006: ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
Official title: Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin d Deficiency
Vitamin B 12 Deficiency
Protein Deficiency
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: Vizera d.o.o.
name: Frutarom Etol d.o.o.
name: European Regional Development Fund
First posted: 2022-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age \> 65 years) who tested study products. On screening visit, participants underwent measuring of body weight \& height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.
Primary purpose: TREATMENT

Brief 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.

Detailed 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?

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

Primary outcomes:
measure: Change in serum vitamin D levels will be determined
timeFrame: 56 days
Secondary outcomes:
measure: Change in dietary protein intake will be determined
timeFrame: 56 days
measure: Change in serum vitamin B12 levels will be determined
timeFrame: 56 days
measure: Malnutrition at baseline
timeFrame: baseline
Other outcomes:
Locations:
city: Trzin
country: Slovenia
facility: VIZERA
Study officials:
affiliation: Researcher
name: Mojca Miholič, MD
role: PRINCIPAL_INVESTIGATOR
References: