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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin B 12 Deficiency; Vitamin d Deficiency; Protein Deficiency
• Intervention / Treatment: Dietary supplement: Use of placebo food supplement; Dietary supplement: Use of food supplement

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?

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Trzin, Slovenia
    • Vizera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Subjects taking control product	Dietary supplement: Use of placebo food supplement; On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end
Experimental: Active group; Subjects taking active product	Dietary supplement: Use of food supplement; On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day). Intervention end on day 56 ±3 (fasted condition): Measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight & height Collecting data regarding the palatability of the product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum vitamin D levels will be determined	Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary protein intake will be determined	Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.	56 days
Change in serum vitamin B12 levels will be determined	Serum level of vitamin B12 will be measured before and after the intervention for each individual.	56 days
Malnutrition at baseline	Risks for malnutritition at baseline will be assessed using dietary records (3x24h food record: energy, protein and plasma concentration of 25-OH-D and vitamin B12.	baseline

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: European Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.
• Investigators: Principal Investigator: Mojca Miholič, MD, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): May 5, 2020
• Study Completion (Actual): June 29, 2020

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Protein Deficiency
• Other Study ID Numbers: 2020/1-ET-SK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No