NCT04175353

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 14, 2019

Last Update Submit

November 22, 2019

Conditions

Postprandial Hyperglycemia

Keywords

older peoplenutritiondairyberriespostprandialglucoseinsulin

Outcome Measures

Primary Outcomes (2)

  • Change in postprandial glucose

    Changes in plasma glucose concentration within 3 hrs after meal

    3 hrs

  • Change in postprandial insulin

    Changes in plasma insulin concentration within 3 hrs after meal

    3 hrs

Secondary Outcomes (3)

  • Change in postprandial free fatty acids

    3 hrs

  • Change in postprandial satiety scores assessed by using visual analogy scales

    3 hrs

  • Heart rate variability

    3 hrs

Study Arms (5)

Dairy snack

EXPERIMENTAL

Drink high in milk protein, 250 ml

Dietary Supplement: Dairy snack

Orange juice

ACTIVE COMPARATOR

Regular orange juice, 250 ml

Dietary Supplement: Dairy snack

Berry snack 1

EXPERIMENTAL

Bilberry-blackcurrant purée, 139 g

Dietary Supplement: Berry snack

Berry snack 2

EXPERIMENTAL

Lingonberry purée, 122 g

Dietary Supplement: Berry snack

Berry soup

ACTIVE COMPARATOR

Bilberry soup, 250 ml

Dietary Supplement: Berry snack

Interventions

Dairy snackDIETARY_SUPPLEMENT

The effects of dairy snack are compared with orange juice.

Dairy snackOrange juice
Berry snackDIETARY_SUPPLEMENT

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

Berry snack 1Berry snack 2Berry soup

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Home-dwelling

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, Finland

Location

Related Publications (1)

  • 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.

    PMID: 36184209DERIVED

MeSH Terms

Conditions

HyperglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Riitta Törrönen, PhD

    University of Eastern Finland, Institute of Public Health and Clinical Nutrition

    PRINCIPAL INVESTIGATOR

  • Marjukka Kolehmainen, Professor

    University of Eastern Finland, Institute of Public Health and Clinical Nutrition

    PRINCIPAL INVESTIGATOR

  • Mika Tarvainen, PhD

    University of Eastern Finland, Department of Applied Physics

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 25, 2019

Study Start

February 1, 2016

Primary Completion

June 2, 2016

Study Completion

December 31, 2016

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)