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

NCT05661006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

  • Vitamin d Deficiency
  • Vitamin B 12 Deficiency
  • Protein Deficiency

Interventions

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

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

Sponsors & Collaborators

  • Vizera d.o.o.

    collaborator INDUSTRY

  • Frutarom Etol d.o.o.

    collaborator INDUSTRY

  • European Regional Development Fund

    collaborator OTHER

  • Institute of Nutrition, Slovenia (Nutris)

    lead OTHER

Principal Investigators

  • Mojca Miholič, MD · Researcher

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2020-05-05
Completion
2020-06-29

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05661006 on ClinicalTrials.gov