Clinical trial NCT05389618: Dietary Challenges in the Population of Nursing Homes' Residents
Official title: Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, Slovenia
name: University Medical Centre Ljubljana
name: Slovenian Research Agency
First posted: 2022-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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).


Eligibility 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:

* 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)

Primary outcomes:
measure: Assessment of protein intake
timeFrame: 1 year
measure: Assessment of energy intake
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of inadequate vitamin D status
timeFrame: 1 year
measure: Assessment of inadequate folate status
timeFrame: 1 year
measure: Assessment of inadequate vitamin B12 status
timeFrame: 1 year
measure: Assessment of inadequate iron status
timeFrame: 1 year
measure: Assessment of anemia
timeFrame: 1 year
Other outcomes:
measure: Nutritional intakes
timeFrame: 1 year
measure: Body mass index
timeFrame: 1 year
measure: Prevalence of sarcopenia
timeFrame: 1 years
Locations:
city: Ljubljana
country: Slovenia
facility: Nutrition Institute, Ljubljana
Study officials:
affiliation: Nutrition Institute, Ljubljana
name: Živa Lavriša, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrition Institute, Ljubljana
name: Igor Pravst, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Public Health, Slovenia
name: Ivan Eržen, PhD
role: STUDY_CHAIR
affiliation: University Medical Centre Ljubljana
name: Nadan Gregorič
role: STUDY_CHAIR
References: