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

Primary Purpose

Nutrition Disorders in Old Age

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dairy- and berry-based snacks
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutrition Disorders in Old Age focused on measuring Older people, Nutrition, Snack, Dairy, Protein, Berries

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Home care clients of the City of Kuopio

Exclusion Criteria:

  • Advanced dementia

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Snack

Reference

Arm Description

Dairy- and berry-based snacks

No snacks

Outcomes

Primary Outcome Measures

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.
Albumin
Change in plasma albumin concentration
Prealbumin
Change in plasma prealbumin concentration
Hand grip strength
Change in grip strength of both hands

Secondary Outcome Measures

Body mass index (BMI)
Change in BMI
Mid-arm muscular area (MMA)
Change in MMA
Hemoglobin
Change in blood hemoglobin concentration
C-reactive protein (CRP)
Change in plasma high-sensitivity CRP concentration
Activity and sleep assessed by ActiGraph monitoring
Changes in several parameters describing physical activity and quality of sleep
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.

Full Information

First Posted
November 20, 2017
Last Updated
December 14, 2017
Sponsor
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03352388
Brief Title
Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders in Old Age
Keywords
Older people, Nutrition, Snack, Dairy, Protein, Berries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Snack
Arm Type
Experimental
Arm Description
Dairy- and berry-based snacks
Arm Title
Reference
Arm Type
No Intervention
Arm Description
No snacks
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy- and berry-based snacks
Intervention Description
High-protein dairy-based products and energy-enriched berry products for three months
Primary Outcome Measure Information:
Title
Nutritional status
Description
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.
Time Frame
Baseline and 3 months
Title
Albumin
Description
Change in plasma albumin concentration
Time Frame
Baseline and 3 months
Title
Prealbumin
Description
Change in plasma prealbumin concentration
Time Frame
Baseline and 3 months
Title
Hand grip strength
Description
Change in grip strength of both hands
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Description
Change in BMI
Time Frame
Baseline and 3 months
Title
Mid-arm muscular area (MMA)
Description
Change in MMA
Time Frame
Baseline and 3 months
Title
Hemoglobin
Description
Change in blood hemoglobin concentration
Time Frame
Baseline and 3 months
Title
C-reactive protein (CRP)
Description
Change in plasma high-sensitivity CRP concentration
Time Frame
Baseline and 3 months
Title
Activity and sleep assessed by ActiGraph monitoring
Description
Changes in several parameters describing physical activity and quality of sleep
Time Frame
Baseline and 3 months
Title
Health-related quality of life
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Home care clients of the City of Kuopio Exclusion Criteria: Advanced dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riitta Törrönen, PhD
Organizational Affiliation
Senior Researcher
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irma Nykänen, PhD
Organizational Affiliation
Senior Researcher
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ursula Schwab, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Tarvainen, PhD
Organizational Affiliation
Senior Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30498827
Citation
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.
Results Reference
derived

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

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