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

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dairy snack
Berry snack
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postprandial Hyperglycemia focused on measuring older people, nutrition, dairy, berries, postprandial, glucose, insulin

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Dairy snack

Orange juice

Berry snack 1

Berry snack 2

Berry soup

Arm Description

Drink high in milk protein, 250 ml

Regular orange juice, 250 ml

Bilberry-blackcurrant purée, 139 g

Lingonberry purée, 122 g

Bilberry soup, 250 ml

Outcomes

Primary Outcome Measures

Change in postprandial glucose
Changes in plasma glucose concentration within 3 hrs after meal
Change in postprandial insulin
Changes in plasma insulin concentration within 3 hrs after meal

Secondary Outcome Measures

Change in postprandial free fatty acids
Changes in plasma free fatty acid concentration within 3 hrs after meal
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.
Heart rate variability
Electrocardiography monitoring for assessment of several variables of heart rate variability

Full Information

First Posted
November 14, 2019
Last Updated
November 22, 2019
Sponsor
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT04175353
Brief Title
Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People
Acronym
MAVIRE2
Official Title
Tailored Food Solutions for Improving Nutrition and Well-being in Older People: Effects on Postprandial Responses
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
June 2, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
older people, nutrition, dairy, berries, postprandial, glucose, insulin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dairy snack
Arm Type
Experimental
Arm Description
Drink high in milk protein, 250 ml
Arm Title
Orange juice
Arm Type
Active Comparator
Arm Description
Regular orange juice, 250 ml
Arm Title
Berry snack 1
Arm Type
Experimental
Arm Description
Bilberry-blackcurrant purée, 139 g
Arm Title
Berry snack 2
Arm Type
Experimental
Arm Description
Lingonberry purée, 122 g
Arm Title
Berry soup
Arm Type
Active Comparator
Arm Description
Bilberry soup, 250 ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy snack
Intervention Description
The effects of dairy snack are compared with orange juice.
Intervention Type
Dietary Supplement
Intervention Name(s)
Berry snack
Intervention Description
The effects of two berry snacks are compared with berry soup.
Primary Outcome Measure Information:
Title
Change in postprandial glucose
Description
Changes in plasma glucose concentration within 3 hrs after meal
Time Frame
3 hrs
Title
Change in postprandial insulin
Description
Changes in plasma insulin concentration within 3 hrs after meal
Time Frame
3 hrs
Secondary Outcome Measure Information:
Title
Change in postprandial free fatty acids
Description
Changes in plasma free fatty acid concentration within 3 hrs after meal
Time Frame
3 hrs
Title
Change in postprandial satiety scores assessed by using visual analogy scales
Description
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
Title
Heart rate variability
Description
Electrocardiography monitoring for assessment of several variables of heart rate variability
Time Frame
3 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riitta Törrönen, PhD
Organizational Affiliation
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjukka Kolehmainen, Professor
Organizational Affiliation
University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Tarvainen, PhD
Organizational Affiliation
University of Eastern Finland, Department of Applied Physics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36184209
Citation
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.
Results Reference
derived

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

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