Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People

Study Overview
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Brief Summary
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Malnutrition or its risk is common among older people, especially among those receiving home care services. It impairs the quality of life of the older people and results in significant costs to society. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense snacks is recommended. The purpose of this study is to investigate the effects of dairy- and berry-based snack consumption on nutritional and functional status and quality of life among vulnerable older people at home care.

Official Title
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Tailored Food Solutions for Improving Nutrition and Well-being in Older People. Effects on Nutritional and Functional Status and Quality of Life in Older People at Home Care

Conditions
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Nutrition Disorders in Old Age

Intervention / Treatment
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* Dietary Supplement: Dairy- and berry-based snacks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Home care clients of the City of Kuopio Exclusion Criteria: Advanced dementia

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snack<br>Dairy- and berry-based snacks | Dietary Supplement: Dairy- and berry-based snacks<br>* High-protein dairy-based products and energy-enriched berry products for three months<br>|
| No Intervention: Reference<br>No snacks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Nutritional status is assessed by the Mini Nutritional Assessment (MNA) test which is a validated and standardized tool for detecting malnutrition and its risk in older people. Scores 24.0 - 30.0 indicate normal nutritional status, scores 17.0 - 23.5 risk of malnutrition and scores < 17.0 malnutrition. Change in the MNA score is determined. | Baseline and 3 months | 
| Albumin | Change in plasma albumin concentration | Baseline and 3 months | 
| Prealbumin | Change in plasma prealbumin concentration | Baseline and 3 months | 
| Hand grip strength | Change in grip strength of both hands | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) | Change in BMI | Baseline and 3 months | 
| Mid-arm muscular area (MMA) | Change in MMA | Baseline and 3 months | 
| Hemoglobin | Change in blood hemoglobin concentration | Baseline and 3 months | 
| C-reactive protein (CRP) | Change in plasma high-sensitivity CRP concentration | Baseline and 3 months | 
| Activity and sleep assessed by ActiGraph monitoring | Changes in several parameters describing physical activity and quality of sleep | Baseline and 3 months | 
| Health-related quality of life | Health-related quality of life is assessed by the 15D instrument. It is a generic, standardized instrument consisting of 15 dimensions: moving, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental functioning, discomfort/symptoms, depression, distress, vitality, and sexual activity. Each dimension is divided into five levels by which more or less an attribute is distinguished. In this study 15D is used as single index score measure. The single index score (15D score) is calculated from the health state descriptive system through the use of an additive three-stage valuation model based on the multiattribute utility theory. The preference weights for the 15 dimensions, and their levels have been elicited from representative population samples. The 15D score is on a 0-1 scale, where 1 stands for full health and 0 being dead. Change in the 15D score is determined, and a change of ±.03 is clinically important. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older people, Nutrition, Snack, Dairy, Protein, Berries