NUTRICARE: Dietary Challenges in the Population of Nursing Homes' Residents

• Sponsor: Nutrition Institute, Slovenia (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05389618
• Collaborator: National Institute of Public Health, Slovenia (Other), University Medical Centre Ljubljana (Other), Slovenian Research Agency (Other)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 19.3
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Nutritional Status; Nutrient Deficiency; Micronutrient Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Iron-deficiency; Protein Deficiency; Sarcopenia; Obesity; Diet	Other: Diagnostic Tests

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia
• Anticipated Study Start Date: May 23, 2022
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Assessment of protein intake [1 year]

   epidemiology of protein intake will be investigated from food records [g/day]

2. Assessment of energy intake [1 year]

   epidemiology of energy intake will be investigated from food records [kJ/day]

Secondary Outcome Measures

1. Assessment of inadequate vitamin D status [1 year]

   epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration

2. Assessment of inadequate folate status [1 year]

   epidemiology of folate status will be investigated using serum folate concentration

3. Assessment of inadequate vitamin B12 status [1 year]

   epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration

4. Assessment of inadequate iron status [1 year]

   epidemiology of iron status will be investigated using serum ferritin concentration

5. Assessment of anemia [1 year]

   epidemiology of anemia will be investigated using serum haemoglobin concentration

Other Outcome Measures

1. Nutritional intakes [1 year]

   epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]

2. Body mass index [1 year]

   Weight and height will be combined to report BMI in kg/m^2 and providing insights into prevalence of overweight/obesity

3. Prevalence of sarcopenia [1 years]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nutrition Institute, Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

• Nutrition Institute, Slovenia
• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Project web site

Publications

None provided.

• Responsible Party: Nutrition Institute, Slovenia
• ClinicalTrials.gov Identifier: NCT05389618
• Other Study ID Numbers: Z3-3213; KME 0120-531/2021/13
• First Posted: May 25, 2022
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nutrition Institute, Slovenia: dietary intake; nutritional status; micronutrients; Slovenia; Europe
• Additional relevant MeSH terms: Sarcopenia; Vitamin D Deficiency; Vitamin B 12 Deficiency; Protein Deficiency; Folic Acid Deficiency

Study Results

No Results Posted as of May 25, 2022