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CompletedNCT04175353MAVIRE2Updated Nov 25, 2019

Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People

An interventional study of Dairy snack and Berry snack in Postprandial Hyperglycemia, sponsored by University of Eastern Finland. Completed at 1 site in Finland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by University of Eastern Finland · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Feb 2016, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Malnutrition or its risk is common among older people. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of nutrient- and energy-dense snacks is recommended. The study examines the post-meal responses to dairy- and berry-based snacks tailored for older people. The plasma concentrations of glucose, insulin and free fatty acids are measured during three hours after snack consumption. In addition, subjective satiety responses and heart rate variability are recorded.

02

Conditions studied

  • Postprandial Hyperglycemia

Keywords

  • older people
  • nutrition
  • dairy
  • berries
  • postprandial
  • glucose
  • insulin
03

In context

Hyperglycemia

713 studies on the registry are indexed under Hyperglycemia; 108 are open to participants now.

This study's enrollment of 26 is below the median of 45 across 531 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

University of Eastern Finland is the lead sponsor of 53 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Home-dwelling

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Type 1 diabetes
  • Type 2 diabetes treated with oral medications or insulin
  • Cognitive impairment
  • Antibiotic medication within the past 3 months
  • Blood donation within the past month
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Dairy snack

    Drink high in milk protein, 250 ml

    Dietary Supplement: Dairy snack

  • Active comparator
    Orange juice

    Regular orange juice, 250 ml

    Dietary Supplement: Dairy snack

  • Experimental
    Berry snack 1

    Bilberry-blackcurrant purée, 139 g

    Dietary Supplement: Berry snack

  • Experimental
    Berry snack 2

    Lingonberry purée, 122 g

    Dietary Supplement: Berry snack

  • Active comparator
    Berry soup

    Bilberry soup, 250 ml

    Dietary Supplement: Berry snack

Interventions

  • Dietary supplementDairy snack

    The effects of dairy snack are compared with orange juice.

  • Dietary supplementBerry snack

    The effects of two berry snacks are compared with berry soup.

06

What researchers measure

Primary outcomes

  1. Change in postprandial glucose

    Changes in plasma glucose concentration within 3 hrs after meal

    Time frame: 3 hrs

  2. Change in postprandial insulin

    Changes in plasma insulin concentration within 3 hrs after meal

    Time frame: 3 hrs

Secondary outcomes

  1. Change in postprandial free fatty acids

    Changes in plasma free fatty acid concentration within 3 hrs after meal

    Time frame: 3 hrs

  2. Change in postprandial satiety scores assessed by using visual analogy scales

    Visual analogue scales (VAS) are used to assess satiety and other related subjective sensations (fullness, hunger, desire to eat, alertness) within 3 hrs after meal. Each VAS consists of a 100-mm horizontal line anchored with verbal descriptions at each end expressing the weakest (0 mm) or strongest (100 mm) statement of sensation. Results are scores between 0 and 100.

    Time frame: 3 hrs

  3. Heart rate variability

    Electrocardiography monitoring for assessment of several variables of heart rate variability

    Time frame: 3 hrs

07

Study locations

1 site
  • University of Eastern Finland
    Kuopio, Finland
08

References and documents

Publications

  • Torronen R, Jarvinen S, Kolehmainen M. Postprandial glycemic responses to a high-protein dairy snack and energy-enriched berry snacks in older adults. Clin Nutr ESPEN. 2022 Oct;51:231-238. doi: 10.1016/j.clnesp.2022.08.026. Epub 2022 Aug 30. PubMed 36184209 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Jun 2016, 4 months.

Of 199 non-industry interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 4 months is below that.

Counting every sponsor, half of 216 studies reached it within 14 months; a quarter within 7 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2019
First posted
Nov 25, 2019
StartActual
Feb 1, 2016
Primary completionActual
Jun 2, 2016
CompletionActual
Dec 31, 2016
Last update
Nov 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04175353
Lead sponsor
University of Eastern Finland
Responsible party
Sponsor
First posted
Nov 25, 2019
Start date
Feb 1, 2016
Primary completion
Jun 2, 2016
Completion
Dec 31, 2016
Last update
Nov 25, 2019

Study contacts

Riitta Törrönen, PhD
principal investigator · University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Marjukka Kolehmainen, Professor
principal investigator · University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Mika Tarvainen, PhD
principal investigator · University of Eastern Finland, Department of Applied Physics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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