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

Nutrition Disorders in Old Age Clinical Trial

— MAVIRE1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352388
• Other study ID #: MAVIRE 247124
• Secondary ID: 4249/31/2014
• Status: Completed
• Phase: N/A
• First received: November 20, 2017
• Last updated: December 14, 2017
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2017
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Home care clients of the City of Kuopio

Exclusion Criteria:

• Advanced dementia

Related Conditions & MeSH terms

• Nutrition Disorders
• Nutrition Disorders in Old Age

Intervention

Dietary Supplement:
• Dairy- and berry-based snacks
High-protein dairy-based products and energy-enriched berry products for three months

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Albumin	Change in plasma albumin concentration	Baseline and 3 months
Primary	Prealbumin	Change in plasma prealbumin concentration	Baseline and 3 months
Primary	Hand grip strength	Change in grip strength of both hands	Baseline and 3 months
Secondary	Body mass index (BMI)	Change in BMI	Baseline and 3 months
Secondary	Mid-arm muscular area (MMA)	Change in MMA	Baseline and 3 months
Secondary	Hemoglobin	Change in blood hemoglobin concentration	Baseline and 3 months
Secondary	C-reactive protein (CRP)	Change in plasma high-sensitivity CRP concentration	Baseline and 3 months
Secondary	Activity and sleep assessed by ActiGraph monitoring	Changes in several parameters describing physical activity and quality of sleep	Baseline and 3 months
Secondary	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