Nutritional StatusNUTRICARENCT05389618
Dietary Challenges in the Population of Nursing Homes' Residents
An observational study of Nutritional Status and Nutrient Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency
- What is being tested?
- Diagnostic Tests
- How many people
- 300 participants
- Where
- 1 siteSlovenia
- Study dates
- 26 May 2022to 31 Dec 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia
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).
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency
- Being tested
- Diagnostic Tests
- Keywords
- dietary intake, nutritional status, micronutrients, Slovenia, Europe
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency, Anemia, Iron-Deficiency, Protein Deficiency, Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestsOther
Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)
| Study group | Role | What they receive |
|---|---|---|
| Older adults 65-80 years | Not described Receives: Other: Diagnostic Tests | |
| Older adults above 80 years | Not described Receives: Other: Diagnostic Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of protein intake
epidemiology of protein intake will be investigated from food records [g/day]
Measured: 1 year
Assessment of energy intake
epidemiology of energy intake will be investigated from food records [kJ/day]
Measured: 1 year
Secondary outcomes (5)
Assessment of inadequate vitamin D status
epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration
Measured: 1 year
Assessment of inadequate folate status
epidemiology of folate status will be investigated using serum folate concentration
Measured: 1 year
Assessment of inadequate vitamin B12 status
epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration
Measured: 1 year
Assessment of inadequate iron status
epidemiology of iron status will be investigated using serum ferritin concentration
Measured: 1 year
Assessment of anemia
epidemiology of anemia will be investigated using serum haemoglobin concentration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start26 May 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, University Medical Centre Ljubljana, Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Živa Lavriša, PhD, Principal investigator, Nutrition Institute, LjubljanaIgor Pravst, PhD, Study director, Nutrition Institute, LjubljanaIvan Eržen, PhD, Study chair, National Institute of Public Health, SloveniaNadan Gregorič, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389618
- Sponsor's protocol ID
- Z3-3213
- Other IDs
- KME 0120-531/2021/13
- Acronym
- NUTRICARE
- Status last verified
- Jun 2023
- First submitted
- 19 May 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided