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Completed

NCT Number: NCT05661006

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

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIZERA

Trzin, Slovenia

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of food supplement

Dietary 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

Use of placebo food supplement

Dietary 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

Primary outcomes

  1. Change in serum vitamin D levels will be determined

    Time frame: 56 days

    Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.

Secondary outcomes

  1. Change in dietary protein intake will be determined

    Time frame: 56 days

    Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.

  2. Change in serum vitamin B12 levels will be determined

    Time frame: 56 days

    Serum level of vitamin B12 will be measured before and after the intervention for each individual.

  3. Malnutrition at baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • European Regional Development Fund
  • Frutarom Etol d.o.o.
  • Vizera d.o.o.

Registry information

Official study title

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

Acronym: ETOL-Elderly

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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