Dietary Challenges in the Population of Nursing Homes' Residents

Obesity Clinical Trial

— NUTRICARE  

Official title:

Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia

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
• 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
• 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)

Related Conditions & MeSH terms

• Diet
• Folic Acid Deficiency
• Iron-deficiency
• Micronutrient Deficiency
• Nutrient Deficiency
• Nutritional Status
• Obesity
• Protein Deficiency
• Sarcopenia
• Vitamin B 12 Deficiency
• Vitamin D Deficiency

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

External Links

•   Project web site