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Enrolling by invitationNCT05389618NUTRICAREUpdated Jun 22, 2023

Dietary Challenges in the Population of Nursing Homes' Residents

An observational study in Nutritional Status, Nutrient Deficiency and Micronutrient Deficiency, sponsored by Nutrition Institute, Slovenia. Enrolling by invitation at 1 site in Slovenia. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Nutrition Institute, Slovenia · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
300
Ages
65 Years and older
Sex
All
01

Study summary

To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).

02

Conditions studied

  • Nutritional Status
  • Nutrient Deficiency
  • Micronutrient Deficiency
  • Vitamin D Deficiency
  • Vitamin B 12 Deficiency
  • Folic Acid Deficiency
  • Iron-deficiency
  • Protein Deficiency
  • Sarcopenia
  • Obesity
  • Diet

Keywords

  • dietary intake
  • nutritional status
  • micronutrients
  • Slovenia
  • Europe
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This observational study is conducted on randomly selected residents of 18 different nursing homes, located in all regions in Republic of Slovenia, using described inclusion/exclusion criteria.

Inclusion criteria

  • Age 65 years or older
  • Has been in the elderly care institution (nursing home) for at least 3 months before joining the study
  • Care category: I., II., III.A
  • The person can feed independently or with minimal help
  • Agrees to be included in the study (signed a statement of consent)

Exclusion criteria

Exclusion Criteria:

  • The person has an acute illness
  • The person is a dialysis patient
  • Temporary special diet / fasting / gastrointestinal cleansing (i.e. due to (pre)planned examinations / procedures)
  • The person cannot be weighted by the usual weighing scale or chair weighing scale
  • Protégé of the day care center
  • Located in the red zone of the elderly care institution (nursing home) (COVID-19 measures)
04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • Older adults 65-80 years

    Other: Diagnostic Tests

  • Older adults above 80 years

    Other: Diagnostic Tests

Interventions

  • OtherDiagnostic Tests

    Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)

05

What researchers measure

Primary outcomes

  1. Assessment of protein intake

    epidemiology of protein intake will be investigated from food records \[g/day\]

    Time frame: 1 year

  2. Assessment of energy intake

    epidemiology of energy intake will be investigated from food records \[kJ/day\]

    Time frame: 1 year

Secondary outcomes

  1. Assessment of inadequate vitamin D status

    epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration

    Time frame: 1 year

  2. Assessment of inadequate folate status

    epidemiology of folate status will be investigated using serum folate concentration

    Time frame: 1 year

  3. Assessment of inadequate vitamin B12 status

    epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration

    Time frame: 1 year

  4. Assessment of inadequate iron status

    epidemiology of iron status will be investigated using serum ferritin concentration

    Time frame: 1 year

  5. Assessment of anemia

    epidemiology of anemia will be investigated using serum haemoglobin concentration

    Time frame: 1 year

Other outcomes

  1. Nutritional intakes

    epidemiology of dietary intake of nutrients and fibre will be investigated from food records \[g/day\]

    Time frame: 1 year

  2. Body mass index

    Weight and height will be combined to report BMI in kg/m\^2 and providing insights into prevalence of overweight/obesity

    Time frame: 1 year

  3. Prevalence of sarcopenia

    epidemiology of sarcopenia will be investigated using EWGSOP2 (European Working Group on Sarcopenia in Older People 2) criteria and estimated ASM (apendicular skeletal muscle mass)

    Time frame: 1 years

06

Study locations

1 site
  • Nutrition Institute, Ljubljana
    Ljubljana, 1000, Slovenia
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05389618
Lead sponsor
Nutrition Institute, Slovenia
Collaborators
National Institute of Public Health, Slovenia, University Medical Centre Ljubljana, Slovenian Research Agency
Responsible party
Sponsor
First posted
May 25, 2022
Start date
May 26, 2022
Primary completion
Sep 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jun 22, 2023

Study contacts

Živa Lavriša, PhD
principal investigator · Nutrition Institute, Ljubljana
Igor Pravst, PhD
study director · Nutrition Institute, Ljubljana
Ivan Eržen, PhD
study chair · National Institute of Public Health, Slovenia
Nadan Gregorič
study chair · University Medical Centre Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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