Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People (MAVIRE2)

November 22, 2019 updated by: University of Eastern Finland

Tailored Food Solutions for Improving Nutrition and Well-being in Older People: Effects on Postprandial Responses

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kuopio, Finland
        • University of Eastern Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Home-dwelling

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dairy snack
Drink high in milk protein, 250 ml
The effects of dairy snack are compared with orange juice.
Active Comparator: Orange juice
Regular orange juice, 250 ml
The effects of dairy snack are compared with orange juice.
Experimental: Berry snack 1
Bilberry-blackcurrant purée, 139 g
The effects of two berry snacks are compared with berry soup.
Experimental: Berry snack 2
Lingonberry purée, 122 g
The effects of two berry snacks are compared with berry soup.
Active Comparator: Berry soup
Bilberry soup, 250 ml
The effects of two berry snacks are compared with berry soup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postprandial glucose
Time Frame: 3 hrs
Changes in plasma glucose concentration within 3 hrs after meal
3 hrs
Change in postprandial insulin
Time Frame: 3 hrs
Changes in plasma insulin concentration within 3 hrs after meal
3 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postprandial free fatty acids
Time Frame: 3 hrs
Changes in plasma free fatty acid concentration within 3 hrs after meal
3 hrs
Change in postprandial satiety scores assessed by using visual analogy scales
Time Frame: 3 hrs
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.
3 hrs
Heart rate variability
Time Frame: 3 hrs
Electrocardiography monitoring for assessment of several variables of heart rate variability
3 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 2, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MAVIRE2 247124
  • 4249/31/2014 (Other Grant/Funding Number: Tekes)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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