NCT05389618

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 19, 2022

Last Update Submit

June 20, 2023

Conditions

Keywords

dietary intakenutritional statusmicronutrientsSloveniaEurope

Outcome Measures

Primary Outcomes (2)

  • Assessment of protein intake

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

    1 year

  • Assessment of energy intake

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

    1 year

Secondary Outcomes (5)

  • Assessment of inadequate vitamin D status

    1 year

  • Assessment of inadequate folate status

    1 year

  • Assessment of inadequate vitamin B12 status

    1 year

  • Assessment of inadequate iron status

    1 year

  • Assessment of anemia

    1 year

Other Outcomes (3)

  • Nutritional intakes

    1 year

  • Body mass index

    1 year

  • Prevalence of sarcopenia

    1 years

Study Arms (2)

Older adults 65-80 years

Other: Diagnostic Tests

Older adults above 80 years

Other: Diagnostic Tests

Interventions

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

Older adults 65-80 yearsOlder adults above 80 years

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Links

Biospecimen

Retention: NONE RETAINED

Blood samples will be freezed for possible further analyses on markers related with nutrition \& health

MeSH Terms

Conditions

Vitamin D DeficiencyVitamin B 12 DeficiencyFolic Acid DeficiencyAnemia, Iron-DeficiencyProtein DeficiencySarcopeniaObesity

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesVitamin B DeficiencyAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionBody Weight

Study Officials

  • Živa Lavriša, PhD

    Nutrition Institute, Ljubljana

    PRINCIPAL INVESTIGATOR
  • Igor Pravst, PhD

    Nutrition Institute, Ljubljana

    STUDY DIRECTOR
  • Ivan Eržen, PhD

    National Institute of Public Health, Slovenia

    STUDY CHAIR
  • Nadan Gregorič

    University Medical Centre Ljubljana

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 25, 2022

Study Start

May 26, 2022

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations