Dietary Challenges in the Population of Nursing Homes' Residents (NUTRICARE)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Iron-deficiency; Vitamin D Deficiency; Nutritional Status; Sarcopenia; Vitamin B 12 Deficiency; Folic Acid Deficiency; Diet; Nutrient Deficiency; Micronutrient Deficiency; Protein Deficiency
• Intervention / Treatment: Other: Diagnostic Tests

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Nutrition Institute, Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Older adults 65-80 years	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)
Older adults above 80 years	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of protein intake	epidemiology of protein intake will be investigated from food records [g/day]	1 year
Assessment of energy intake	epidemiology of energy intake will be investigated from food records [kJ/day]	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of inadequate vitamin D status	epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration	1 year
Assessment of inadequate folate status	epidemiology of folate status will be investigated using serum folate concentration	1 year
Assessment of inadequate vitamin B12 status	epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration	1 year
Assessment of inadequate iron status	epidemiology of iron status will be investigated using serum ferritin concentration	1 year
Assessment of anemia	epidemiology of anemia will be investigated using serum haemoglobin concentration	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional intakes	epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]	1 year
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
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

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: National Institute of Public Health, Slovenia; University Medical Centre Ljubljana; Slovenian Research Agency
• Investigators: Principal Investigator: Živa Lavriša, PhD, Nutrition Institute, Ljubljana; Study Director: Igor Pravst, PhD, Nutrition Institute, Ljubljana; Study Chair: Ivan Eržen, PhD, National Institute of Public Health, Slovenia; Study Chair: Nadan Gregorič, University Medical Centre Ljubljana

Publications and helpful links

Helpful Links

• Project web site

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: nutritional status; micronutrients; Europe; dietary intake; Slovenia
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Iron Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Muscular Atrophy; Atrophy; Vitamin B Deficiency; Vitamin D Deficiency; Sarcopenia; Vitamin B 12 Deficiency; Folic Acid Deficiency; Protein Deficiency; Iron Deficiencies
• Other Study ID Numbers: Z3-3213; KME 0120-531/2021/13 (Other Identifier: National Medical Ethics Committee (Slovenia))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No