Obesity Clinical Trial
— NUTRICAREOfficial title:
Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia
Verified date | June 2023 |
Source | Nutrition Institute, Slovenia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Slovenia | Nutrition Institute, Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Nutrition Institute, Slovenia | National Institute of Public Health, Slovenia, Slovenian Research Agency, University Medical Centre Ljubljana |
Slovenia,
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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