Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People (MAVIRE1)

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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders in Old Age
• Intervention / Treatment: Dietary supplement: Dairy- and berry-based snacks

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland
    • University of Eastern Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Home care clients of the City of Kuopio

Exclusion Criteria:

• Advanced dementia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Snack; Dairy- and berry-based snacks	Dietary supplement: Dairy- and berry-based snacks; High-protein dairy-based products and energy-enriched berry products for three months
No Intervention: Reference; No snacks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Investigators: Principal Investigator: Riitta Törrönen, PhD, Senior Researcher; Principal Investigator: Irma Nykänen, PhD, Senior Researcher; Principal Investigator: Ursula Schwab, PhD, Professor; Principal Investigator: Mika Tarvainen, PhD, Senior Researcher

Publications and helpful links

General Publications

• Nykanen I, Torronen R, Schwab U. Dairy-Based and Energy-Enriched Berry-Based Snacks Improve or Maintain Nutritional and Functional Status in Older People in Home Care. J Nutr Health Aging. 2018;22(10):1205-1210. doi: 10.1007/s12603-018-1076-7.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Nutrition; Dairy; Older people; Protein; Snack; Berries
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: MAVIRE 247124; 4249/31/2014 (Other Grant/Funding Number: Tekes)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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