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Nutrition Disorders in Old AgeMAVIRE1NCT03352388

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

A study testing Dairy- and berry-based snacks in people with Nutrition Disorders in Old Age, run by University of Eastern Finland at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Nutrition Disorders in Old Age
What is being tested?
Dairy- and berry-based snacks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteFinland
Study dates
Sep 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Home care clients of the City of Kuopio

Who cannot join

  • Advanced dementia

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University of Eastern Finland

    Kuopio

Other trials in Finland

About this study

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

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.

Being tested
Dairy- and berry-based snacks
Keywords
Older people, Nutrition, Snack, Dairy, Protein, Berries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dairy- and berry-based snacksDietary supplement

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

Study groups in NCT03352388
Study groupRoleWhat they receive
SnackExperimentalDairy- and berry-based snacks
Receives: Dietary Supplement: Dairy- and berry-based snacks
ReferenceNo interventionNo snacks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 3 months

  2. Albumin

    Change in plasma albumin concentration

    Measured: Baseline and 3 months

  3. Prealbumin

    Change in plasma prealbumin concentration

    Measured: Baseline and 3 months

  4. Hand grip strength

    Change in grip strength of both hands

    Measured: Baseline and 3 months

Secondary outcomes (6)

  1. Body mass index (BMI)

    Change in BMI

    Measured: Baseline and 3 months

  2. Mid-arm muscular area (MMA)

    Change in MMA

    Measured: Baseline and 3 months

  3. Hemoglobin

    Change in blood hemoglobin concentration

    Measured: Baseline and 3 months

  4. C-reactive protein (CRP)

    Change in plasma high-sensitivity CRP concentration

    Measured: Baseline and 3 months

  5. Activity and sleep assessed by ActiGraph monitoring

    Changes in several parameters describing physical activity and quality of sleep

    Measured: Baseline and 3 months

  6. 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.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2017
  2. Study startSep 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352388
Sponsor's protocol ID
MAVIRE 247124
Other IDs
4249/31/2014
Acronym
MAVIRE1
Status last verified
Dec 2017
First submitted
20 Nov 2017
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30498827

Questions about this trial

What is this clinical trial studying?

A study testing Dairy- and berry-based snacks in people with Nutrition Disorders in Old Age, run by University of Eastern Finland at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03352388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.

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