NCT03352388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

November 20, 2017

Last Update Submit

December 14, 2017

Conditions

Nutrition Disorders in Old Age

Keywords

Older peopleNutritionSnackDairyProteinBerries

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Body mass index (BMI)

    Baseline and 3 months

  • Mid-arm muscular area (MMA)

    Baseline and 3 months

  • Hemoglobin

    Baseline and 3 months

  • C-reactive protein (CRP)

    Baseline and 3 months

  • Activity and sleep assessed by ActiGraph monitoring

    Baseline and 3 months

  • +1 more secondary outcomes

Study Arms (2)

Snack

EXPERIMENTAL

Dairy- and berry-based snacks

Dietary Supplement: Dairy- and berry-based snacks

Reference

NO INTERVENTION

No snacks

Interventions

Dairy- and berry-based snacksDIETARY_SUPPLEMENT

High-protein dairy-based products and energy-enriched berry products for three months

Snack

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Home care clients of the City of Kuopio

You may not qualify if:

  • Advanced dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, Finland

Location

Related Publications (1)

  • 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.

    PMID: 30498827DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 15, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)