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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05389618
Other study ID # Z3-3213
Secondary ID KME 0120-531/202
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 26, 2022
Est. completion date December 31, 2023

Study information

Verified date June 2023
Source Nutrition Institute, Slovenia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Slovenia Nutrition Institute, Ljubljana Ljubljana

Sponsors (4)

Lead Sponsor Collaborator
Nutrition Institute, Slovenia National Institute of Public Health, Slovenia, Slovenian Research Agency, University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other Nutritional intakes epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day] 1 year
Other Body mass index Weight and height will be combined to report BMI in kg/m^2 and providing insights into prevalence of overweight/obesity 1 year
Other 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) 1 years
Primary Assessment of protein intake epidemiology of protein intake will be investigated from food records [g/day] 1 year
Primary Assessment of energy intake epidemiology of energy intake will be investigated from food records [kJ/day] 1 year
Secondary Assessment of inadequate vitamin D status epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration 1 year
Secondary Assessment of inadequate folate status epidemiology of folate status will be investigated using serum folate concentration 1 year
Secondary Assessment of inadequate vitamin B12 status epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration 1 year
Secondary Assessment of inadequate iron status epidemiology of iron status will be investigated using serum ferritin concentration 1 year
Secondary Assessment of anemia epidemiology of anemia will be investigated using serum haemoglobin concentration 1 year
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